Prescribed Reading: Data, arrests, pricing batter pharma

A weekly guide to the goings-on in the biopharma industry.

Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

In case you missed it

Mergers & analysis

A data-heavy week continued to be dominated by the uncertainty Donald Trump's victory instilled in the market as news trickled out about the people that may be filling the government ranks under the new administration.

Despite all that, Valeant Pharmaceuticals continued to steal headlines. The U.S. Attorney's Office for the Southern District of New York announced charges against a former Valeant executive and the ex-boss of Philidor Rx Services for defrauding the Canadian pharma in a kickback scheme. Philidor was at the center of the complicated accounting scandal which tanked the company's stock a little over a year ago. 

Based on the laundry list of information that was subpoenaed by the Attorney's office, this will likely just be the first of many new developments in the case against Valeant. Expect further scrutiny on the company's drug pricing practices, accounting missteps and lack of due diligence — which may bleed into Valeant's efforts to shop its portfolio around to pay down debts. 

Clinically relevant

Clinical data rolled in this week from a slew of conferences across the country, including the American Heart Association meeting and the Liver Meeting hosted by the American Association for the Study of Liver Diseases, among several others.

Merck & Co. and AbbVie each presented eight-week data for their hepatitis C combinations. While the HCV population has been thinning due to the high cure rates of Gilead's franchise drugs, there are still plenty of patients who have unmet needs. With this new data in hand, the HCV market could soon see shorter pan-genotypic treatment regimens and more competition.

Data from Amgen and Novartis for their episodic migraine drug erenumab is changing the landscape for neuroscience, giving the pair a leg up on Alder Biopharmaceuticals, Eli Lilly & Co. and Teva Pharmaceuticals.

Meanwhile, Gilead has been having a rough week. The hep C giant announced last night it is dumping GlobeImmune's hep B drug from its pipeline after some iffy data. That decision comes just days after Gilead announced mixed results in two Phase 3 myelofibrosis studies which could mean its JAK inhibitor momelotinib won't be able to compete with Incyte's Jakafi, should it reach the market.

Highly regulated

Drug pricing in the U.S. remains an area without strict regulations. Despite sector stock gains since Donald Trump was elected the country's next president, a Reuters poll showing Americans are calling for healthcare reform could mean the desire is there to support more regulation of drug pricing.

Already companies are feeling intense pressure from payers, most notably insulin makers like Novo Nordisk. 

In the wake of increased scrutiny and recent probes from Congress, companies are working to clean up their acts. Teva Pharmaceuticals continued its sweeping restructuring as it tries to get back to its generics roots. Creating a compliant corporate culture were dominant themes during Teva's discussion of operations.

Adding fuel to the drug pricing fire, was a report released this week by the Centers for Medicare and Medicaid Services (CMS) that showed the average cost of many drugs continued to rise steadily, with the prices for 11 drugs more than doubling since last year. 

Off the bench

Accelerating early drug development is a problem that pharma (and others) are on a mission to solve.

Pfizer furthered its dedication to that endeavor through its latest tie-up with the National Cancer Institute, agreeing to conduct preclinical and clinical trials using three of Pfizer's immunotherapy compounds, including its PD-L1 inhibitor avelumab that is partnered with Merck KGaA.

Elsewhere, Roche promised to dedicate $100 million to support collaboration with 21 academic centers. The global cancer immunotherapy Centers of Research Excellence (imCORE) will share expertise, data and technology in an effort to accelerate drug development.

Companies and universities across Europe are joining together to combat antimicrobial resistance. The Innovative Medicines Initiative (IMI)-funded New Drugs 4 Bad Bugs (ND4BB) project COMBACTE-NET announced this week that Da Volterra and The Medicines Co. have joined the public-private partnership. The network currently comprises more than 750 hospitals, 450 laboratories and over 1,000 investigators in 42 European countries, according to a statement

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Filed Under: Drug Discovery Clinical Trials Mergers and Acquisitions / Deals