Week 35-39: September News Highights

Posted on October 1, 2018 in Uncategorized

September got the best of us here at WMC, so instead of a weekly roundup, this newsletter takes a look at some of the interesting headlines from the month.

Progress and comment from the US FDA

The US FDA has outlined how it plans to combat the spread of drug-resistant superbugs and also called for changes to reimbursement models to encourage pharmaceutical industry investment in R&D. Agency commissioner Scott Gottlieb shared details of the plan last week. On the regulatory side, the focus would be on creating a framework that facilitates development, promoting appropriate use of antibiotics, setting up enhanced surveillance systems and exploring alternative treatment approaches.

CIDRAP focused on Gottlieb’s comments about reinvigorating antibiotic R&D and better stewardship, welcoming the plan as a positive step. Meanwhile, in its coverage STAT noted the agency is also speaking with private organizations like the Gates Foundation about its proposed changes to the reimbursement system.

The FDA recently said it has taken an important step towards tackling the epidemic of prescription opioid abuse that has emerged in the US in recent years.

Last week the FDA announced on its site that they had approved the final version of an Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). According to the agency, the plan includes measures to help better communicate the risks of using opioid pain medications to patients and doctors.

The REMS applies to immediate-release (IR) opioid analgesics as well as extended-release and long-acting (ER/LA) formulations. In addition, the program also requires that developers make training available to health care providers. The training would focus on when it is appropriate to prescribe these medicines, as well as how best to monitor patients who are on them—critically, the goal is to make sure that the patients who actually need the medications receive them and stay safe while using them.

FDA Commissioner Scott Gottlieb put the measures in context. “Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use.

He added that, “Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products–to a more stringent set of requirements.”

MedPage today welcomed the inclusion of immediate-release opioid formulations in the new REMS. It also pointed out that although the scheme mandates that manufacturers create training programs, doctor participation is mandatory and has the greatest impact on success.

In its coverage of the topic, European Pharmaceutical Review also focused on the FDA’s call for appropriate prescribing. The publication highlighted that despite being expanded, the REMS still only applies to 62 up to 347 opioid products sold in the US, meaning more progress is yet to be made.

The US FDA has also announced they will update cybersecurity guidelines for medical devices and drug, device combos this year according to Politico. Concerns exist that medical devices, including implants used to administer drugs, could be hacked and have been growing for several years. A study suggested device manufacturers’ are not doing enough to prevent their products being broken into. More recently industry has called on the US Government and the FDA to provide more effective guidelines.

Drug and insurance headlines

First “made in China” drug cleared by national regulators. Hutchison China MediTech’s cancer drug Elunate (fruquintinib) has become the first medicine discovered, developed and trialed solely in the country to be approved by national regulators. According to Reuters, the colorectal cancer medication was cleared by China’s National Medical Products Administration last week based on its performance in a randomized clinical trial conducted in the country. Whether Chi-Med and partner Eli Lilly plan to seek approval for Elunate in the US is unclear. Reuters states such a move is a certainty, however, PMLive reports that a decision has not yet been made. Even if Elunate remains a China only product, most observers agree its approval speaks volumes about the development of the country’s biotechnology sector and regulatory infrastructure.

The UK says Gilead’s CAR-T therapy, Yescarta, is too expensive to be provided by the NHS, Britain’s state-funded health service. Yescarta, used to treat two forms of aggressive non-Hodgkin lymphoma, is priced at $373,000 in the US, while the UK did not disclose its price on their market. Read the full Reuters report.

Australia’s CannPal Animal Therapeutics has begun testing its range of cannabis-based pain medicines in clinical trials according to a report in Business News Australia. The new drug will treat family pets suffering from osteoarthritis. CannPal plans to file an Investigative New Animal Drug application with the US FDA, looking for a late 2019 pilot dose determination study.

The US FDA says it need more time to review Acorda Therapeutics’ Parkinson’s disease ‘off symptoms’ drug candidate Inbrija (levodopa inhalation powder). GEN said the agency extended the review to give it more time to assess additional CMC data filed by Acorda. News of the decision – which pushes back the PDUFA date from October to January next year – follows days after a US Court invalidated four related to Acorda’s MS drug Ampyra.

The Indian Government has introduced a health insurance scheme. The system – nicknamed ‘Modicare’ in a reference to Indian Prime Minister Narendra Modi – is intended to provide free coverage for half a billion of the county’s poorest citizens.

According to Medical Express, Modicare will grant a healthcare budget per individual based on that person’s wealth. For example, lowest-income families will be provided 500,000 rupees ($6,900 USD) in annual health insurance to treat serious ailments.

A Reuters report earlier this year confirmed that the Indian Government has set aside $1.7bn to fund the program.

And in not so feel good insurance news, a Dutch health insurer called Menzis has sued AstraZeneca alleging the firm abused its position in the market and maintained an unnecessarily high price for its product, Seroquel. The team claims they did this through ‘evergreening’ of its patents according to analysis by Medicallaw&

STAT also reported on the Menzis claim towards AstraZeneca. This has been a hot topic of discussion as the industry looks to address and eradicate abuse of position. This particular case highlights how patients can be unfairly forced to pay more—in this case, for AZN’s Seroquel— because lower-cost generic alternatives were precluded from becoming available.

FDA news: FDAZilla reported that the agency issued seven warning letters to drug and device manufacturers between September 9 and 16, citing sterility deficiencies among others. Time to clean up the act—literally!

And both the EMA and US FDA have detected a second contaminant in drugs containing valsartan sourced from Chinese API firm Zhejiang Huahai Pharmaceutical. The agencies found low levels of a compound called N‑nitrosodiethylamine (NDEA) in batches of drugs during tests prompted by the earlier detection of a compound called N‑nitrosodimethylamine (NDMA). The EMA and FDA said that like NDMA, NDEA is a potential carcinogen. The European agency also said medicines containing valsartan made by two separate Chinese suppliers – Zhejiang Huahai and Zhejiang Tianyu – are no longer being distributed in the EU.

Client news you can use

Pall Biotech has been making strides with its strategic partnering approach. Two recent announcements cover deals with biologics consulting firm, Celltheon and biosimilar focused Aetos Biologics.

In a live interview with Bioprocess Insider, a Pall representative offered greater insight into the deals and how Pall is working to make the technologies more accessible.

The agreement with Celltheon combines Celltheon’s proprietary SMART Expression Platform with Pall’s comprehensive portfolio of bioprocessing equipment and consumables to offer customers integrated systems to develop novel biologics.

The second deal will aim to integrate Pall’s bioprocessing tech with Aetos Biologics’ biosimilar cell line platform.

Research news

Alzheimer’s could be caused by infection according to research by Leslie Norins, founder of According to an article in NPR, Norins says the progression of Alzhemier’s disease shares many of the characteristics of a viral or bacterial infection.

A substantial amount of the funding cancer researchers get from industry goes unreported, according to a study by Oregon Health and Science University (OHSU) and Oklahoma State University (OSU). The research letter, published in JAMA Oncology, stated that funding was not fully disclosed when trials were submitted for approval, indicating that pharmaceutical companies may be creating a conflict of interest with the FDA approval process. It also noted that payments received from pharmaceutical companies may be impacting how physicians prescribe medications. The conclusion – here – is based on the assessment of nearly 8,000 trials. The review revealed that around 90% of completed university clinical studies failed to report results to the EU Clinical Trials Register (EUCTR) within a year as they are required to do under EU guidelines.

Vertex Pharmaceuticals and CRISPR Therapeutics have become the first US firms to launch a trial of a CRISPR-based therapy. The firms filed details of the study on last week, explaining they have started testing their co-development product CTX001 in people with Transfusion-Dependent β-Thalassemia at a hospital in Germany. According to the Scientist CTX001 is designed to treat diseases characterized by a deficiency in the production of hemoglobin. CRISPR Therapeutics announced that it was planning the trial last year. At the time the firm’s CEO Sam Kulkarni told Wired “Just three years ago we were talking about Crispr-based treatments as sci-fi fantasy, but here we are.”

A recent animal study points to a potential universal flu vaccine that targets a highly immunogenic epitope of limited variability; the strain has shown promise in preclinical studies.

Researchers at University of Oxford’s Department of Zoology shared details of their work in a study in Nature. They explained that unlike conventional influenza vaccines, their candidate would not need to be updated each flu season to make sure it protects against the strain of viruses circulating at the time. Injecting the epitope in question into mice induces protective immunity against a wide-range of influenza virus strains – including the H1N1 virus responsible for the 1918 pandemic which is thought to have killed as many as 100 million people worldwide. The researchers wrote, “The identification of epitopes of limited variability offers a mechanism by which a universal influenza vaccine can be created; these vaccines would also have the potential to protect against newly emerging influenza strains.”

And finally…

The temperature increases resulting from climate change will increase the amount of food crops eaten by pests according to a study published in Science. The authors’ models show that for the three most important grain crops—wheat, rice, and maize—yield lost to insects will increase by 10 to 25% per degree Celsius of warming, hitting hardest in the temperate zone. The Atlantic covered the research here.

Robo doc? AI will not replace doctors anytime soon says WEF after the Switzerland-based WEF assessed the impact artificial intelligence (AI) is having on the healthcare sector in a bid to predict how such technology will shape the sector in future. According to the WEF, to date AI has been of most use in medical imaging. However, while computers handing many of the functional aspects of such work, assessments and interpretation still requires human intervention. The WEF also pointed to things like patient communication as areas where AI is unlikely to replace human doctors, suggesting “Explaining the many nuances of a mysterious disease such as cancer requires emotional intelligence and the ability to build trust with patients by delivering information effectively.”

While last month was quite the whirlwind, the fun does not stop there! We are gearing up for the last quarter of the year with an interesting October spent mostly in Europe. First, we kick things off at CPhI Worldwide in Madrid, Spain and then our team heads to Belgium before getting back to WMC’s new home in Boston, MA.

Will we see you in Spain? Drop us a line at to set a meeting, if so.