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Pfizer price hikes on pause after Trump pressure

In doing so, the pharma appeared to issue a warning of its own, suggesting prices could rise in 2019 unless Trump's pricing blueprint takes effect.

Marketing

Sanofi shuts down French facility due to pollution complaint

Work at the Mourenx plant was immediately halted to sort out pollution problems associated with Depakine production.

Manufacturing

Pfizer rejiggers business units

After moving around some puzzle pieces, the big pharma will have three distinct units operating independently. 

Mergers and Acquisitions / Deals

Otsuka drops $430M to beef up antibody drug development

An acquisition deal for Visterra hands the Japanese pharma a slate of preclinical candidates and access to the target's Hierotope technology.

Mergers and Acquisitions / Deals

Celgene's blood drug scores again in Phase 3

Luspatercept now holds late-stage victories for both beta-thalassemia and myelodysplastic syndromes, and should hit regulators' desks next year.

Clinical Trials

Aquinox cuts staff by 50% in wake of late-stage miss

The study failure, announced two weeks ago, led Aquinox to halt all further development for its sole clinical candidate rosiptor.

Clinical Trials

Genevant inks development deal with BioNTech

The "Vant" focused on RNA therapeutics has agreed to co-develop mRNA drugs for rare diseases.

Mergers and Acquisitions / Deals

Azar says 'change is coming' for 340B

The HHS secretary spoke at an industry conference of the "need to disrupt the entire system of rebates" on the same day President Trump criticized Pfizer for hiking drug prices. 

Regulatory / Compliance

Axovant parades new preclinical therapy, much to investor delight

A licensing deal with Benitec Biopharma provides Axovant a much-needed pipeline expansion, as well as underscores its interest in gene therapy.

Clinical Trials

Vertex spars with UK's May over Orkambi pricing

After the NHS rejected an offer on pricing of the biotech's cystic fibrosis drugs, the company hinted its future in the country could be in jeopardy.

Marketing

CTI cancer drug faces clouded future after study failure

A confirmatory study designed to substantiate Pixuvri's benefit in non-Hodgkin lymphoma fell short of its goal, sending shares in the drugmaker tumbling. 

Clinical Trials

KemPharm shoots for ADHD filling in 2019

The biotech said the study met its endpoint, and intends to file for approval in early 2019.

Clinical Trials

Regulus lays off 60% of staff, halts development

After a clinical hold led the biotech to scrap its lead drug last year, the company is pausing development of other programs as it weighs a way forward. 

Clinical Trials

Boehringer increases manufacturing capacity in China

By adding a new fill-and-finish line at its Shanghai site, the German drugmaker aims to be a "one-stop shop" for GMP contract manufacturing.

Manufacturing

Biogen Alzheimer's drug shows unexpected signs of promise

Positive secondary results for the anti-amyloid drug come six months after an initial failure led many to discount its chances.

Clinical Trials

Prior authorization limits would be 'reasonable' for CGRP drugs, ICER says

While Amgen won some credit for pricing its new migraine drug lower than expected, payers could still act as a gatekeeper for access to CGRP inhibitors. 

Marketing

After failure, Zynerba shifts gears to save cash

Following unfavorable results from a Phase 1 study, the company will focus on its other asset, in Fragile X and epilepsy.

Clinical Trials

Catalent expands with $133M deal for Juniper

Acquiring the Boston-based company will hand Catalent a clinical development and manufacturing center in the U.K.

Mergers and Acquisitions / Deals

Sanofi expands China presence with new R&D hub

It's a bet on the growing role China looks set to play in global clinical trials of new medicines. 

Manufacturing

Novartis set to threaten Mylan's EpiPen franchise

The Swiss pharma will provide commercial might for a competing epinephrine autoinjector. 

Mergers and Acquisitions / Deals

In FDA first, Dermira secures approval for excessive sweating drug

The OK offers some relief to Dermira, which saw its stock plummet earlier this year on the unexpected failure of a closely watched drug. 

Clinical Trials

Tecentriq extends streak with win in breast cancer trial

Roche claimed Tecentriq's success in IMpassion 130 as the first positive Phase 3 study of an immunotherapy in triple-negative breast cancer. An overall survival benefit, however, has yet to be established.

Clinical Trials

Celgene gets key Phase 3 win with anemia drug

After a rough year, the big biotech finally got some good news. Celgene and partner Acceleron plan to file for approval in early 2019.

Clinical Trials

Galapagos posts 'underwhelming' cystic fibrosis results, boosting Vertex

In a further blow, Galapagos' partner AbbVie decided to back out of development of another triple combination study, raising doubts about the smaller biotech's program.

Clinical Trials

Biogen pays $700M to up stake in Samsung Bioepis

But the investment might not be for the long term. Biogen has signaled it might seek to trade or otherwise exit the joint venture down the road. 

Mergers and Acquisitions / Deals