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FDA grants priority review to Merck Ebola vaccine

(News)

Merck’s Biologics License Application for V920 has been accepted by the FDA as the company continues to expand investigational supply to support international Ebola outbreak response.

Sanofi partners with Happify Health for digital therapeutics

(News)

The two will be developing and studying an app to help manage and improve psychological outcomes in people with multiple sclerosis.

Making the case for Indian generic drug manufacturing

(Article)

In response to the growing regulatory environment, pharmaceutical companies in India continue to strengthen their processes, while improving automation, operating procedures and quality management systems.

AstraZeneca diabetes drug gets fast track designation for heart indication

(News)

The prospects for an AstraZeneca diabetes drug receiving a major new indication are looking even brighter.

Possible carcinogen found in popular heartburn meds

(News)

Regulators in the U.S. and EU are taking a closer look at medication containing ranitidine after the presence of a probable carcinogen was found in several samples.

Lundbeck buys Alder, eyeing migraine drug

(News)

Denmark’s Lundbeck has agreed to buy Alder BioPharmaceuticals in a deal valued at almost $2 billion, hoping to profit from a potential blockbuster migraine drug.

Purdue Pharma files for bankruptcy as part of opioid settlement

(News)

Purdue Pharma filed for Chapter 11 bankruptcy in New York as part of its framework for settling litigation with states and local governments in a massive opioid lawsuit.

Pharma in review: trending stories 9/13/19

(News)

pharma manufacturing news in review

Bayer reduces management board amid ongoing company shake-up

(News)

Bayer’s quest to reduce its workforce has traveled all the way up into the company’s highest ranks.

Sanofi forks over $260M to end diabetes partnership

(News)

Sanofi will pay Lexicon Pharmaceuticals $260 million to terminate a partnership related to the development of a diabetes drug.

Vertex to sell cystic fibrosis drugs in Scotland

(News)

Amid Vertex’s continuing drug pricing battle with British regulators, the drugmaker has signed a deal to make two of its cystic fibrosis drugs available in Scotland.

CAR-T may treat heart disease, says study

(News)

A first-of-its-kind study by researchers at Penn Medicine found that CAR-T cell therapy may be a viable treatment option for heart disease.

Data analytics moves beyond Dilbert

(Article)

Why pharma manufacturers shouldn’t get stuck in a comic

Mallinckrodt offloads BioVectra for $250 million

(News)

The company has agreed to sell its contract manufacturing unit to alleviate some of its debt woes as it faces a myriad of opioid lawsuits.

FDA OKs Xeris Pharma low blood sugar pen

(News)

The results of two Phase 3 studies were presented at the American Diabetes Association’s 78th Scientific Sessions.

Making antibody medicines manufacturing a reality

(Article)

Drug Development: Exploring the technologies needed to achieve automatic control of cell culture processes.

Experimental Lilly med shrank nearly 70% of tumors in lung cancer trial

(News)

The drug LOXO-292 was acquired by the drugmaker in the beginning of the year when it took over Loxo Oncology for $8 billion.

Novartis investigational lung cancer therapy grabs breakthrough status

(News)

The U.S. FDA has granted Breakthrough Therapy designation to Novartis' capmatinib, which the drugmaker aims to file for approval later this year to treat a mutated form of lung cancer.

Novartis CEO pledges to proactively speed up disclosing data integrity issues

(News)

The company head promised to voluntarily notify the FDA within five business days of receipt of any credible allegation related to data integrity impacting any pending application.

Amgen experimental lung cancer drug shows promise in study

(News)

More than half of patients with an advanced form of lung cancer initially responded to an experimental Amgen drug that targets a genetic driver of the disease.

FDA commish frontrunner emerges

(News)

Top MD Anderson Cancer Center exec Stephen Hahn has emerged as the frontrunner to be the next FDA commissioner

BMS Opdivo fails in brain cancer study

(News)

Bristol-Myers Squibb said its blockbuster cancer immunotherapy, Opdivo, failed to meet a main goal of a late-stage trial, testing it in patients with a rare type of brain cancer.

Pharma in review: trending stories 9/6/19

(News)

pharma manufacturing news in review

The surge in cancer drug approvals — By the numbers

(Article)

A new report shows that the number of FDA approvals for cancer drugs has shot up in the last few decades. What’s behind the rise?

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