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Morgantown restructuring costs weigh on Mylan

High restructuring costs and reduced manufacturing at the West Virginia plant have poked a hole in Mylan's finances.

Regulatory / Compliance

Mallinckrodt's rare disease drug set back by confusing trial result

Study results were supposed to show the drugmaker's treatment slowed disease progression more than placebo. Instead, both active and placebo groups showed no disease progression.

Clinical Trials

Earnings reveal pharma's mixed feelings on Trump drug pricing proposal

A plan that would shake up how CMS pays for Medicare Part B drugs could leave the bottom lines of major players like Roche, Amgen and Bristol-Myers exposed, according to analysts.​

Marketing

5 election takeaways for pharma

Democrats took back the House on Tuesday, raising the prospect of more scrutiny on drug pricing. Experts, however, don't expect a major deal with President Trump.

Regulatory / Compliance

Merrimack cuts 60% of jobs, narrows R&D focus

Since selling Onivyde to Ipsen, the company has struggled to find research success and is now shrinking its workforce and pipeline again.

Corporate News

Sage depression drug to cost between $20K and $35K, if approved

Zulresso is currently under review by the FDA for postpartum depression, with a decision expected in December.

Regulatory / Compliance

Despite Trulicity success, Lilly can't escape diabetes concerns

Analysts grilled the drugmaker on a Tuesday earnings call about risks to its broader diabetes portfolio, including Jardiance and Basaglar. 

Corporate News

Nektar lures Pfizer with promise of combo immunotherapy

A new research collaboration suggests the big pharma sees potential for Nektar's drug to boost response rates to immunotherapy. The jury on NKTR-214 is still out, however. 

Clinical Trials

Beleaguered Akorn hit with lengthy FDA inspection report

Already under fire for data integrity issues, Akorn has been issued a Form 483 detailing a slate of quality control violations. 

Regulatory / Compliance

Abeona inks deal with Regenxbio for gene therapy vector supply

Viral vectors are a key component of gene therapy development. Securing rights to Regenxbio's AAV9 vector could help accelerate Abeona's R&D work. 

Mergers and Acquisitions / Deals

Lilly strengthens Trulicity's leading position with REWIND results

Wall Street analysts note data from the cardiovascular outcomes study could help differentiate the diabetes drug in the crowded GLP-1 market.

Clinical Trials

Another opioid approval incites questions, criticism

The chairman of an FDA advisory committee has warned Dsuvia's approval will lead to diversion, abuse and death.

Regulatory / Compliance

Novartis gives up on biosimilar Rituxan in US

An additional ask from the FDA, which had rejected Novartis' copycat version earlier this year, seems to have changed the big pharma's thinking. 

Marketing

Pfizer extends cancer drug approval streak with OK for Lorbrena

Lorbrena is Pfizer's third oncology therapy to be cleared by the FDA within the past two months, following Vizimpro and Talzenna.

Regulatory / Compliance

FDA panel vote lifts approval prospects for Sage's Zulresso

A key question, though, centers on how Sage's drug should be administered if approved. A strict REMS requirement could limit commercial prospects.

Regulatory / Compliance

Alkermes depression drug approval odds slim after negative FDA panel vote

An agency advisory panel voted 21-2 against recommending approval for ALKS-5461, sending shares in the company sliding. 

Clinical Trials

Humira biosimilar discounting 'aggressive' as competition enters in Europe

AbbVie, though, is confident it can deliver double-digit earnings growth in 2019 despite the biosimilar headwinds in Europe to Humira.

Marketing

Insulin drugmakers under scrutiny for pricing, patent practices

Reports from a Congressional caucus and a consumer group could fuel further criticism of the top diabetes pharma companies, in particular Sanofi.

Marketing

Shingrix gives GSK a near-term boost

Questions on future growth still loom large, however, amid a pipeline revamp and competitive pressures in the pharma's core therapeutic areas.

Marketing

Sanofi inks research deal with Denali in neurological, inflammatory diseases

The French pharma will pay $125 million upfront to get in on development of Denali's RIPK1 inhibitors, targeting several diseases including ALS and MS.

Drug Discovery

Allergan axes expansion plan, but reiterates commitment to Waco plant

With generic competition for Restasis looming, Allergan is stepping back from previous plans to expand its Texas manufacturing facility.

Manufacturing

Gilead's stock wobbles on HIV pricing concerns

In a cost-saving effort, United Healthcare will offer patients who opt for cheaper HIV drugs prepaid debit cards, spurring concerns Gilead could be exposed to pricing pressures in HIV.

Marketing

Novartis wins US nod for Humira biosimilar, but focus now on Europe

A settlement deal blocks market launch in the U.S. until 2023. In Europe, however, the battle for market share is just beginning. 

Regulatory / Compliance

Astellas invests $257M in trans-Pacific manufacturing build-out

A major focus of the planned construction will be on building capacity for cell therapy and regenerative medicine development.

Manufacturing

Amgen reckons with biosimilar and pricing pressures

The biotech's migraine drug Aimovig continued a strong launch in Q3. But analysts doubted whether Amgen can overcome headwinds from biosimilars and declining legacy products.

Corporate News