Influenza virus mutations prevented during vaccine production

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Duke researchers used a bivalent virus from chicken cells that packaged twice as much protein as a monovalent virus, and vaccinated mice with either the bivalent or monovalent vaccine.

Researchers have discovered how to keep the human influenza virus from mutating during egg-based production, and hence create a more effective flu vaccine.

Vaccine manufacturers have traditionally used chicken eggs to grow the flu virus strains used in the seasonal flu vaccination. But because these human strains frequently mutate to adapt to their environment in eggs, the resulting vaccine is often an imperfect match to the virus it is supposed to protect against.

Researchers at Duke University School of Medicine, whose findings appear in the journal mBio, used a bivalent virus from chicken cells that packaged twice as much protein as a monovalent virus, and vaccinated mice with either the bivalent or monovalent vaccine. They found equal immune responses across the board.

“We have solved a fundamental problem that scientists had accepted would be part of vaccine production – that the virus is always going to mutate if it is grown in eggs,” said Dr Nicholas Heaton, “This research could lead to a significantly cheaper and more efficacious vaccine.”

The researchers identified why the receptor that the virus uses to get into cells is shaped differently in a human nose than it is in a chicken egg. The human virus has to alter the protein it carries with it – so that it can operate in its new locale. Because hemagglutinin (HA) also happens to be the part of the flu vaccine that induces an immune response in people, each mutation renders the vaccine less effective.

The influenza vaccine has been notoriously ineffective. During the 2015-2016 flu season, the vaccine reduced the risk of catching a serious bout of the flu by just 42 percent. Most of the time, the vaccine’s lacklustre performance is blamed on poor strain selection.

Dr Heaton and his team attempted to engineer a virus that would both grow happily in chicken eggs and produce the HA protein required to protect people. They expressed two versions of HA – one adapted to eggs and one adapted to humans – on one virus particle.

“We reasoned that the egg-adapted HA would do all the heavy lifting,” Dr Heaton said. “It could do the virus entry work and just bring the other one along for the ride. In effect, that would alleviate the strong selective pressure on the human HA to mutate.”

Dr Heaton and his team plugged the HA from that infamous Fujian strain that grew so poorly in production that nobody was vaccinated against Fujian that year, into their egg-adapted system and rescued the virus right off the bat. When the two HA proteins were put together, it grew five orders of magnitude more virus.

After the researchers had grown the virus in chicken eggs for a while, they harvested the virus and sequenced the human HA protein. They did not find a single mutation.

“Because viruses typically mutate during vaccine production, manufacturers have to screen for mutations, and decide which ones can be tolerated and which ones can’t,” Dr Heaton said: “If we can eliminate mutations, we can cut back dramatically on production time.”

Though the technology is still in its infancy, the researchers have successfully used it to make bivalent viruses with a half dozen different HA molecules. Currently, they are making their own versions of the vaccines that are under production for the 2017 and 2018 flu seasons, and are planning to test how they differ in terms of growth, genetic stability, and actual protection.

“There’s a laundry list of problems with the flu vaccine, but this is something that we can solve now, not 10 or 15 years down the line,” said Heaton. “We’re not proposing to change any kind of vaccine production or vaccine methods. We’re just proposing to start production with a different virus. It could be a relatively simple fix”.


Over-the-counter devices hold their own against costly hearing aids

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Hearing aids that can cost more than $2,000 apiece are only slightly more effective than some over-the-counter sound-amplification devices that sell for just a few hundred dollars, according to a recent study.

The study bolsters legislation pending in Congress, which would have the Food and Drug Administration set regulations for cheaper over-the-counter products and is designed to make the devices more widely accessible and safer. Consumers with mild to moderate hearing loss would be able to purchase the devices without a prescription and without a medical exam, knowing they meet federal safety standards.

For the study, researchers compared how well 42 older adults with mild to moderate hearing loss repeated sentences spoken in the presence of background noise. The researchers first tested their ability to understand the speaker without any devices. Then they tested the subjects successively with a hearing aid and with five “personal sound amplification products” sold over the counter.

The hearing aid used in the study was a brand commonly dispensed in audiology clinics. The personal sound amplification products (PSAPs) that were selected either had the best electroacoustic properties or were commonly available in retail pharmacies. PSAPs perform like hearing aids but can’t be marketed as hearing aids because they don’t meet standards set by the FDA.

The results, published this month in JAMA, found very little difference between the hearing aid, which costs about $1,900 per ear, and some of the PSAPs, which mostly cost between $300 and $350 each.

On average, study participants were able to accurately repeat about three-quarters of the words spoken to them without using any device. Using the hearing aid boosted their understanding to an average 88.4 percent. And four out of the five PSAPs were nearly as effective as the hearing aid, with average word understanding ranging from 81.4 percent to 87.4 percent. The fifth PSAP performed poorly: People could hear better with their naked ears.

Age-related hearing loss is a common problem, but only about a quarter of the roughly 30 million people who have it use hearing aids, said Nicholas Reed, an audiology instructor at Johns Hopkins School of Medicine who was the study’s lead author.

“That’s a lot of people who aren’t getting in through the door,” he said.

Cost is a deciding factor for many consumers. Medicare doesn’t cover hearing aids, nor do most private health insurance plans.

Identical versions of the bipartisan Over-the-Counter Hearing Act of 2017 were introduced in the House and Senate this year. The text of those bills has been added as an amendment to the FDA Reauthorization Act of 2017, a bill that is key to FDA operations because it sets the government’s system for collecting fees during the drug approval process.

Not surprisingly, hearing aid manufacturers and distributors are against the bill. So are gun owners, who claim that regulating hearing amplifiers, which some hunters use to detect game, is in effect a way to regulate hunting and undermine their Second Amendment rights.

Reed said that by requiring the FDA to issue regulations on over-the-counter hearing aids, the proposed amendment would improve the products sold. Many of them, he said, are not effective and some are dangerous because there’s no control over amplification levels.

“When it gets to a certain amplification, it will just blow your hearing out,” he said. “Over-the-counter hearing measures would regulate these devices and force them to meet standards.”


Unite responds to Sussex job cuts at GSK

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Proposals by GlaxoSmithKline (GSK) to cut up to 240 jobs at its Sussex plant in Worthing have been described as “extremely concerning” and “potentially devastating” by workers’ union Unite.

Last week, the pharmaceutical giant outlined a number of proposals designed to improve the efficiency and competitiveness of its manufacturing network, including plans to sell its Horlicks business in the UK and the closure of the Slough factory where the malted milk drink is produced.

GSK also announced it will be undertaking a strategic review of its cephalosporins antibiotics division with an option to sell the business and its associated manufacturing facilities, including a site in Ulverston. The company will not be proceeding with a previously planned investment to build a biopharmaceutical facility at the Cumbria site.

In a related move, GSK has also decided to outsource some manufacturing activity at its site in Worthing.

According to Unite, the move places 240 jobs at risk.

Regional officer Mick Polleck said: “This is both extremely concerning news – and potentially devastating for the workers and their families as it appeared that GSK was investing significantly at the Worthing operation, and now these job losses are suddenly announced.”

Tony Devlin, national officer for the pharmaceutical industry, added: “We will be meeting with the UK senior management next week to discuss the reasons behind this announcement which has come as a significant blow for Unite members and looking at the detailed business case for these proposed redundancies and changes in national strategy.

“These are skilled jobs that are under threat and we can’t afford to lose such manufacturing posts, with the economic challenges of Brexit looming.

“We will be fighting very hard against any proposal for compulsory redundancies and will be offering the union’s maximum support to our members in the days and weeks ahead at what is a very challenging time.”


Celgene hopes device + drug can tackle aggressive brain tumours

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Celgene aims to boost the effectiveness of its novel drug marizomib for aggressive brain tumour glioblastoma (GBM) by asking patients to wear a special cap.

Marketed by Novocure, the Optune device consists of four inter-connected patches that cover the skull and deliver the company’s patented Tumour Treating Fields (TTFields). These electrical fields travel through the scalp and into brain, where they disrupt cell division in the tumour, whilst leaving healthy tissue intact.

The device gained FDA approval in 2011 for patients with recurrent GBM and in 2015 for patients with newly diagnosed disease – and has already demonstrated its efficacy.

Data show a three-month improvement in overall and progression-free survival for patients using Optune plus standard therapy temozolomide, compared to patients using temozolomide on its own.

Earlier this year, Optune’s evidence base grew with phase 3 data showing its combination with temozolomide improved both two- and five-year survival in newly diagnosed GBM patients from 30% to 43% and 5% to 13% respectively. The results remain the most significant increases in both survival rates reported in a phase 3 GBM trial.

While adding a medical device like Optune into a drug study complicates the trial – and any results – it is hoped the combination could pay off for patients.

Finding a drug to advance treatment of glioblastoma (GBM) is one of the hardest challenges in pharma, and adding the Optune medical device to a phase 1b study of its investigational drug marizomib could help extend the lives of patients.

Despite pharmaceutical innovation transforming the treatment of multiple cancers, GBM has retained a dismal survival rate, with five-year survival rates around 10% in adults.

Acquired from Triphase in November last year, marizomib is a proteasome inhibitor that received Orphan Drug Designation from the FDA in GBM. Celgene is currently testing the drug in multiple blood-based and solid cancers.

The phase 1b study will evaluate the safety of Optune’s use alongside both temozolomide and marizomib in 12 patients with late-stage GBM who have already been treated with temozolomide and radiotherapy.

It will also assess preliminary clinical activity of the combination and its effect on overall and progression-free survival as secondary objectives. The trial will begin in Q3 of this year.

“This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM,” said Principal Investigator Dr Roger Stupp. “I believe that combining Optune with new pharmacologic treatments in clinical trials, like this phase 1b study, will help advance our understanding of how to treat this devastating disease.”

If the study proves positive, the combination therapy could make Celgene a significant player in the therapy area, which immunotherapy leaders Bristol-Myers Squibb and Merck & Co are also trying to break into.

The former looks to be already out of the running, however, as phase 3 results released in April showed Opdivo failed to improve overall survival in recurrent GBM compared to Avastin monotherapy. The latter will test its Keytruda in combination with Agenus’ cancer vaccine Prophage.

Another competitor is Regeneron which is investigating its own PD-1 inhibitor, REGN2810, alongside two immunotherapy candidates from Inovio.

A novel two-part immunotherapy candidate being developed by Tocagen is also in development, and has just gained PRIME status in Europe, to match its Breakthrough Therapy Designation in the US.


Backed by partners at Pfizer, eFFECTOR brings its VC total to $150M as PhII cancer trial looms

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With a big assist from its Big Pharma collaborator Pfizer, San Diego-based eFFECTOR Therapeutics has now added a $38.5 million round to pay for a Phase II program to test the combination of its oral immuno-therapy drug with avelumab (Bavencio) — Pfizer and Merck KGaA’s PD-L1 checkpoint inhibitor.

The round completes a series of moves by eFFECTOR, which has moved from preclinical tests to check on the potential of a combo to early-stage monotherapy work to test the drug in a small group of cancer patients. Pfizer had agreed to share the costs of the coming Phase II trials with eFFECTOR, and Pfizer Venture Investments took the lead on the new round, which brings its total raised to $150 million.

Alexandria Venture Investments also stepped in for the first time, alongside a big syndicate of founding investors that includes a number of corporate venture arms: U.S. Venture Partners, Abingworth, Novartis Venture Fund, SR One, The Column Group, Altitude Life Science Ventures, Sectoral Asset Management, Abbvie Biotech Ventures, BioMed Ventures, and Astellas Ventures.

The biotech’s lead drug is eFT508, an oral inhibitor of MNK 1 and 2 kinases that play a role in evading an immune system attack. About a month ago Pfizer, Merck KGaA and eFFECTOR signed off on a collaboration to fund a split Phase II study that will test a combination of their two therapies against colon cancer with a monotherapy arm for eFT508.

“The primary role is to translationally regulate gene expression,” CEO Steve Worland tells me, with a direct effect on the tumor “as well as the effect on the immune system’s capability to attack the tumor.”

In Worland’s view, the lead drug has potential as a monotherapy, but its best use could well be in combination with checkpoint inhibitors like the PD-L1 drug avelumab or LAG3 or other checkpoints. He expects to have Phase II data available from the program in mid-2018, but Worland isn’t certain that investigators will be able to pull all the numbers together in time for ASCO.

Worland, the former CEO of Anadys, which was acquired by Roche, snagged a $45 million A round to start the company in 2013, then followed that with $56 million more for the B round.


Sanofi and Regeneron win CHMP nod for Dupixent

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European regulatory advisors have given their backing to Sanofi and Regeneron’s Dupixent (dupliumab).

The treatment for adults who are candidates for systemic therapy with moderate-to-severe atopic dermatitis received a positive opinion from this month’s meeting of the EMA’s Committee for Medicinal Products for Human Use (CHMP).

It makes it the first targeted biologic to receive a positive opinion from the CHMP for the disease to date, which could put it in a strong position once it receives marketing authorisation.

Dupixent is designed to specifically inhibit overactive signalling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in atopic dermatitis.

The interleukin-4 (IL-4) and (IL-13) inhibitor will come in a pre-filled syringe for self-administration as a subcutaneous injection every other week and can be used with or without topical corticosteroids.

However, results from the CHRONOS trial showed that the product is even more effective at clearing skin lesions when used in combination with topical corticosteroids.

The CHMP based its opinion on studies from the global LIBERTY atopic dermatitis clinical trials, which incorporated data from nearly 3,000 adult patients with moderate-to-severe atopic dermatitis.

Those studies showed dupliumab avoids steroids and topical prescription therapies of immunosuppressant’s such as cyclosporine and methotrexate, which can cause side effects with chronic use.

In the US, Dupixent is already approved for the treatment of adults priced around $37,000 per patient per year, but had some bad press lately as Amgen sued Sanofi and Regeneron over the drug back in April claiming patient infringement.

In Europe the CHMP’s decisions almost always translate into full approval for the European Union and the final decision on this from the European Commission (EC) is expected in the next three months.


Eli Lilly offers $400M-plus deal to bag an early-stage autoimmune drug from Nektar

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With little more than preclinical data and some initial dosing cohort insights available for review, Eli Lilly is making a $400 million-plus play to buy into an early-stage autoimmune drug at Nektar $NKTR that the pharma giant believes has megablockbuster potential.

Eli Lilly $LLY has agreed to acquire co-development rights on NKTR-358 — which was first dosed in a human in a Phase I study 4 months ago — for $150 million up front plus $250 million in milestones. Lilly will pick up 75% of the Phase II development costs and Nektar will have the opt-in rights on this drug on an indication-by-indication basis.

The drug is designed to activate regulatory T cells by targeting IL-2, an approach Lilly and Nektar believe could put the immune system back on track in fixing autoimmune diseases.

Nektar CEO Howard Robin, who is in no way reluctant to talk up the prospects of the drugs the biotech has in the clinic, cited this drug for its unique qualities in the Q1 call back in April. Here’s what he had to say:

Unlike current immunosuppressant agents, which globally weaken the immune system to only address disease symptoms. NKTR-358 is a first-in-class resolution therapeutic designed to specifically correct the underlying pathology of autoimmune disease. NKTR-358 is the only medicine of its kind in clinical trials. It has the potential to have a profound effect on a number of immune and inflammatory disorders, including lupus, IBD, RA, psoriasis, MS, Type 1 diabetes and even allergy.

With an asset that has this much broad potential in so many indications, we believe the right strategy for NKTR-358 is to seek a co-development and co-promotion partnership with a company that has a strong leadership position in immunology and importantly shares our vision for the broad development of NKTR-358. Our goal is to enter into partnership this year.

Nektar preclinical R&D chief Jonathan Zalevsky, who’s credited as the inventor, added:

Unlike current immunosuppressant agents, which globally weaken the immune system to only address disease symptoms. NKTR-358 is a first-in-class resolution therapeutic designed to specifically correct the underlying pathology of autoimmune disease. NKTR-358 is the only medicine of its kind in clinical trials. It has the potential to have a profound effect on a number of immune and inflammatory disorders, including lupus, IBD, RA, psoriasis, MS, Type 1 diabetes and even allergy.

He went on to say that this is the kind of drug that can be self-administered.

That’s the kind of profile that Lilly — a major player in diabetes — finds attractive. It’s also the kind of big early-stage deal that former CEO John Lechleiter was largely unwilling to pursue. New CEO Dave Ricks, though, has proven eager to add more drugs to the pipeline after a string of new drug approvals capped by a big setback with the FDA’s rejection of baricitinib.

Nektar’s Robin has been wheeling and dealing over the last few months. The company’s IL-2 research has spawned immuno-oncology programs as well as a Takeda partnership in March. That followed a combo deal with Bristol-Myers Squibb last fall. And after adding Phase III data on its abuse-resistant opioid NKTR-181 just days ago, Robin revived talk of a Big Pharma partnership there as well. Nektar, though, also just ran into a setback after European experts snubbed its pitch for an early OK on its cancer drug Onzeald (NKTR-102).


Cyndi Lauper showcases backstage psoriasis woes in Novartis’ new Cosentyx spot

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Cyndi Lauper is back to star in another round of Novartis’ psoriasis marketing.

The ’80s pop music icon, who in 2015 partnered with the Swiss pharma giant and the National Psoriasis Foundation on a disease-awareness push, appears with two other real-life patients in Novartis’ latest Cosentyx spot.

“It was tough getting out there on stage,” she narrates, as the camera shows her in her dressing room, trying to disguise her psoriasis with spray makeup—and failing. The commercial weaves Lauper’s story with those of two other patients, shown struggling with unwanted attention as people around them stare at the red, flaky skin patches caused by the disease.

But the video spot takes a triumphant turn after Lauper declares that “I found something that worked and keeps on working.”

“Never give up,” she urges viewers, adding, “clear skin can last” as she rocks out on stage and then walks into a crowd of adoring fans.

The new work is part of Novartis’ “See Me” campaign, which the company launched last year to “play well with this patient base and further grow the brand,” as then-pharma chief David Epstein told investors on an early 2016 conference call.

The new spot comes in the face of some new competition. Since the Basel-based drugmaker rolled out its first DTC effort in psoriasis, Eli Lilly’s Taltz, Valeant’s Siliq and, most recently, Johnson & Johnson’s Tremfya have arrived on the next-gen psoriasis scene. Those rivals didn’t stop Cosentyx from cracking the blockbuster barrier, though; it racked up $1.13 billion worldwide in 2016.

And as Johnson & Johnson execs recently reassured their own investors, there’s still plenty of market share to go around. “We believe it’s only about 25% to 30% of the patients in that category [who] are actually on some of the newer agents,” CEO Alex Gorsky said. “So that in and of itself represents a significant opportunity.”


Do healthcare cuts risk creating a ‘desert for innovation’ in the UK?

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The world’s biggest drug companies could reconsider their operations in the UK if the country’s new Government doesn’t increase its spending on NHS treatments and patient access to new medicines, according to the Association of the British Pharmaceutical Industry (ABPI).

The body’s manifesto laid out in detail how this extra money should be spent, emphasising the importance of a new industrial strategy and cooperation with Europe. The UK’s pharmaceutical industry is critical to the health of the country’s population and the success of its economy, investing billions of pounds in research and development (R&D) and supporting hundreds of thousands of highly-skilled jobs.

Lack of funding

According to the ABPI’s new president Lisa Anson, if the UK’s Government continues to squeeze NHS funding and does not take this opportunity to cement the country’s position as a global hub for the life sciences industry, it could face an exodus of drug firms and become ‘a desert for healthcare innovation’. Speaking to The Times in April, Anson said that drug companies would delay launching medicines in Britain if there wasn’t enough funding to approve them. She also suggested that without an increase in healthcare funding, companies would not be able to conduct clinical trials because they would not be able to assess potential new drugs against existing treatments if UK patients were not getting them in the first place. Anson added that by rationing healthcare spending, Britain is jeopardising its “research environment and access to new medicines by eroding the competitiveness of a key sector for a short-term affordability issue”, adding that drug companies are “happy to discuss” possible tax increases to cover the cost of more NHS spending. For Anson, the overriding question is “Do we want to improve NHS patient outcomes and ensure Britain continues to be a global player in life sciences, or run the risk of the UK becoming a desert for healthcare innovation?” If the answer is the former, the ABPI has a three-fold solution.

Improving access to medicine

The first priority detailed in the ABPI’s General Election manifesto is to make patient outcomes in the NHS the best in the world, starting by increasing healthcare investment to the G7 average (11.3% of GDP), which would also bring it in line with historic levels. It would also ensure that the UK is in the top quartile of OECD countries for patient access to new cost-effective medicines and vaccines by 2022.

At present, the UK spends a total of 9.9% of its GDP on healthcare, which places it sixth of the G7 nations, only ahead of Italy. This is a situation that has led to patients in the UK not having access to cost-effective new treatments. The government’s analysis shows that for every 100 patients in comparable countries who get access to a new medicine in its first year of launch, just 18 patients in the UK receive the same, on average. An ABPI spokesperson said: “Supporting the NHS so it can embrace and invest in innovation is crucial to providing quality care to more patients within a sustainable budget”, adding that this will also mean that pharmaceutical companies will have the opportunity to forge even better, deeper collaborations with the NHS.

Securing a world-class NHS

Existing collaborations, such as the recently-agreed industry-NHS partnership across Greater Manchester demonstrates the potential of the NHS and industry working together. This is building on the success of the GSK-sponsored Salford Lung Study, the world’s first randomised controlled trial (RCT) that used a single electronic medical record linking primary care, secondary care, and pharmacy data. Focused on real world evidence collection and the use of healthcare data, the collaboration created a Greater Manchester and Pharmaceutical Industry Partnership Group designed to use the unique data and information capabilities of the NHS to discover, develop, and deliver new medicines and treatments for patients.??? It is also allowing Greater Manchester to explore new ways of paying for medicines based on patient outcomes, enabling the £1bn spent on medicines in the region to be as effective as possible. Anson and the ABPI are calling for the government to increase the number of collaborative programmes, such as this one, including investing in infrastructure to enable the collection, access to and use of more real world data, as well as creating between two and four regional data hubs such as Greater Manchester to attract clinical research and improve patients’ access to it. Alongside this, the association supports the creation of a new long-term, voluntary Pharmaceutical Price Regulation Scheme (PPRS) in partnership with the pharma industry, balancing investment in new medicines, value for money for the NHS and the need to maintain a strong industry.

Putting pharma front and centre

The UK is currently recognised as the third largest life sciences cluster in the world, worth £30bn and comprised of more than 5,500 companies directly employing around 140,000 people, who are twice as productive as the UK average. To keep it that way, and in the process attracting significant new international investment, the ABPI is also calling on the government to put the pharmaceutical industry at the heart of its economic policy. According to the association, this should involve: increasing funding for basic science so that the UK reaches a target of 3% of GDP spend on research and development by 2022, attracting global scientists to the UK and encouraging the colocation of commercial discovery and development science, implementing an ‘end to end’ plan to build the pipeline of highly skilled research and innovation talent in the UK, improving the global competitiveness of UK medicines manufacturing, and ensuring the NHS is seen as a global early adopter of new cost-effective medicines and vaccines.

A new relationship with Europe

The importance of negotiating a new relationship with the EU, that secures patient access to medicines and public health and that can be implemented without disruption to patients, cannot be emphasised enough by the ABPI.



“Securing a deal to continue to collaborate on medicines regulation is the best way of ensuring that medicines continue to be developed and delivered.”

Not only should the new relationship achieve alignment between the UK and European regulatory frameworks, it should secure the ability to freely trade and move medicines and pharma supplies across borders and give the UK predictable access to funding and collaboration for scientific research. As an ABPI spokesperson summarises: “The UK and European life sciences industry has regularly highlighted the importance of resolving the regulatory, supply, and trading arrangements for medicines after the UK leaves the EU, and the complexity involved in this process. Securing a deal to continue to collaborate on medicines regulation is the best way of ensuring that medicines continue to be developed and delivered to patients across Europe without disruption or delay.”

Open engagement with business

One of the keys to successfully implementing the steps laid out by the association, and thereby avoiding an exodus of pharmaceutical firms, will be communication between government and business. It’s a point that ABPI CEO Mike Thompson was keen to emphasise following the election.


Thompson said: “In the short-term, we take confidence in the Prime Minister opting for continuity in her cabinet appointments and we would also like to see Number 10 follow through with their pre-election commitment to engage more openly, more proactively and more frequently with business”, adding that beyond taking a pragmatic approach to the real challenges Brexit presents to regulation, trade, and access to talent, the ABPI will be looking for the government to bring forward an industrial strategy that builds upon the UK’s existing strengths. “An effective Life Sciences Industrial Strategy will send a strong message that the UK is open for business and can help cement Britain’s position as a leading global hub for pharmaceuticals. Companies will want to see a clear plan for attracting inward investment; practical measures for developing highly-skilled jobs; and a strategy for improving NHS uptake of innovation, alongside better integration and use of health data.”


Over 3% of all drugs in Indian market not up to standard

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The Central Drugs Standard Control Organisation (CDSCO) tested drugs to determine whether they were of standard quality but found that 946 of the medicines across 66 companies failed the test.

One of the companies responsible for a surprising number of these was Pfizer, having 25 medicines that were not of quality.

The survey is part of an overall push to bring down levels of its substandard drugs to under 2% over the next three years in order to meet global standards. The study tested 47,954 drug samples with 23 different dosage forms drawn from 654 districts of 36 states across India, with CDSCO reporting that 3.16% were not of the required quality.

The thorough geographic scope of the survey was undermined somewhat by Pfizer’s response to its company being named as one of the highest offenders. It was quoted in India’s Business Standard as responding: “We are unable to confirm the authenticity of the products picked or confirm evidence of the alleged deficiencies as the due process of providing a sealed market sample was not followed. Upon testing of control samples at independent FDA approved laboratories, our products were found to be fully compliant with all required specifications. This was duly communicated to the regulatory authorities and no further action was recommended”.

It could be argued that any company, especially one as large as Pfizer, facing such bad PR would mount a counter-attack but the allegation that due process was not followed is particularly damaging to the authority of the CDSCO.

Despite this, the failings of the companies does not boost confidence in a market that has been dogged with warning letters from the FDA regarding manufacturing practices.

The remit for failing the quality control test is relatively broad, including false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test. The report did not specify particularly which drugs had failed, only the number.

The biggest offender on the list was Unicure India Ltd that had 61 not of standard quality (NSQs) discovered, whilst other high-profile offenders were Dr Reddy, with 9, and Cipla, with 7. Those companies that had five failings or fewer were not contained on the list.