French regulators flag critical compliance violations at Chinese heparin plant

The French National Agency for Medicines and Health Products Safety recommended a product recall of drugs manufactured at the Dongying City plant. 

By Shalina Chatlani • March 3, 2016

Sandoz issues major recall for hypertension drug made in India

The recall comes almost a year after the FDA issued a warning letter to three Mylan plants in India for manufacturing violations. 

By Nicole Gray • Feb. 25, 2016

First human trial of optogenetics to treat blindness set to launch

RetroSense Therapeutics plans to test a new gene therapy for the treatment of a degenerative blindness disease in a trial which could have broad implications for the field of optogenetics. 

By Ned Pagliarulo • Feb. 25, 2016

Cipla snatches 1st US manufacturing plant as part of 'landmark acquisition'

The acquisition of the plant in Long Island comes in the wake of Cipla's deals to buy a pair of American biopharma firms—and in the midst of ongoing troubles with the FDA.

By Sy Mukherjee • Feb. 18, 2016

Sun Pharma to seek re-inspection of non-compliant Halol plant

Sun Pharma previously received a warning letter from the FDA due to quality and compliance issues at its Halol manufacturing facility in Gujarat, India. 

By Ned Pagliarulo • Feb. 18, 2016

Eight pharma suppliers band together to improve packaging testing, compatability

Led by a Canadian pharma manufacturer, the newly formed Matrix Alliance includes pharma suppliers from around the world. 

By Nicole Gray • Feb. 18, 2016

Pfizer issues major recall of children's Advil in Canada

The recall stemmed from a change in the emulsifying agent for the liquid suspension dose, which caused separation and clumping in the bottle. 

By Nicole Gray • Feb. 18, 2016

Chasing blockbusters: Does pharma need to change its success strategy?

A new book focusing on the best ways to bring value to healthcare highlights several warning signs that biopharma may want to note as it tries to build winning drugs in a more demanding R&D landscape.

By Sy Mukherjee • Feb. 18, 2016

Global API market ballooning, will hit $186 billion by 2020: report

Even as a large spate of patent expiries hurts the biopharma sector's profitability, the demand for low-cost substitutes has increased, especially for biologics.

By Nicole Gray • Feb. 16, 2016

China's next big move to bolster domestic drug industry: Market consolidation

The Chinese State Council agreed to further boost local pharmaceutical innovation by strengthening R&D and bringing together a fragmented market. 

By Nicole Gray • Feb. 16, 2016

Dr. Reddy's Q3 earnings flat despite FDA woes

The India-based firm has run afoul of the FDA on a number of important quality control issues.

By Nicole Gray • Feb. 11, 2016

Report: US CMO market set to rebound as foreign quality concerns grow

A report from CPhI pointed toward increased regulatory oversight of Asian production markets and shifts towards more complicated biologic development as drivers of U.S. CMO growth. 

By Ned Pagliarulo • Feb. 11, 2016

Taiwan earthquake leaves drug API plants unscathed

While other buildings suffered extensive damage, well-known API firm Scinopharm reported its API facility in Tainan had no structural damage. 

By Nicole Gray • Feb. 11, 2016

In search for specialists, Teva laying off factory workers at UK plant

The company plans to cut a net 60 positions at its Runcorn plant. 

By Nicole Gray • Feb. 11, 2016

From 'hit' to candidate: Inside Sanofi's massive compound sharing agreement with AZ

In an interview with BioPharma Dive, Sanofi's chief scientific officer also discussed how the company hopes to jumpstart its Zika vaccine development. 

By Ned Pagliarulo • Feb. 11, 2016

Egypt facing major drug supply crisis fueled by weak currency & political turmoil

Since the country's political uprising in 2011, the value of the Egyptian pound has declined substantially, making it harder to import essential drugs. 

By Nicole Gray • Feb. 11, 2016

Liability: The big biosim legal scuffle the industry should be anticipating

According to attorneys from Goodwin Procter, there's a pretty major consideration in the biosimilar regulatory and legal sphere which has gone under the industry's radar.

By Sy Mukherjee • Feb. 4, 2016

UK to funnel $160 million into clinical research infrastructure

The funding will be spread over five years, between 2017 and 2022, for renewing investment in clinical research facilities after the current funding expires in March 2017.

By Ned Pagliarulo • Feb. 4, 2016

Allergan's Texas plant primed for expansion, possible job growth

There have been concerns (in some cases, justified) of big job cuts in the wake of Pfizer's proposed megamerger with Allergan.

By Nicole Gray • Feb. 4, 2016

FDA alleges deleted files, hidden data at India's Wockhardt

Upon inspection of Wockhardt's Shendra-based facilities, FDA employees found evidence of inaccurate record-keeping, deleted records, and improperly labeled and filed pharmaceutical ingredients. 

By Nicole Gray • Jan. 28, 2016

Pfizer recalls 3 lots of Lyrica after heat damage

The three lots of Lyrica were manufactured in Germany and have been recalled in the United States and Puerto Rico. 

By Ned Pagliarulo • Jan. 28, 2016

Specialty injectables maker Sagent considering buyout with Cipla, Dr. Reddy's, others

The U.S.-based injectables maker is reportedly being pursued by several major Indian drugmakers.

By Sy Mukherjee • Jan. 28, 2016

Cost control in the time of biopharma consolidation & globalization

Life sciences firms' wave of M&As and shifts abroad has catalyzed deals in other tranches of the supply chain, too.

By Sy Mukherjee • Jan. 21, 2016

Study: FDA scrutiny, other competition likely to eat into Indian pharma growth

FDA efforts to monitor manufacturing quality have already crimped exports from India. Additionally, other lower-cost emerging markets may begin to threaten India's role in the market, according to a study conducted by Assocham-TechSci Research. 

By Nicole Gray • Jan. 21, 2016

Pfizer reportedly mulling production expansion in Russia with Polysan

Other firms have also explored manufacturing plans in the economically beleaguered nation. But political turmoil has continued to be a hurdle. 

By Sy Mukherjee • Jan. 21, 2016