Denying recent reports, India government say it hasn't promised to restrict compulsory licensing

Two U.S. business groups previously indicated India had privately promised to restrict use of the legal tool for commercial purposes. 

By Nicole Gray • March 23, 2016

Scientists develop new type of stem cell with only half a genome

The new cells could have important implications for genetic research, particularly in precision medicine fields. 

By Ned Pagliarulo • March 17, 2016

Amgen signs 'flexible manufacturing agreement' with CMO Patheon

Looking to supplement its own network, Amgen said the deal would provide it with greater flexibility to meet demand for its products. 

By Ned Pagliarulo • March 17, 2016

Indian Health Ministry bans nearly 350 combo drugs

Fixed dose combinations have proliferated in India, making up nearly half of all drugs on the market in 2014 despite many being unapproved nationwide. 

By Nicole Gray • March 14, 2016

Bispecifics emerging as alternative cancer immunotherapy to CAR-T

Roche and Amgen are pushing the development of bispecifics, a type of cancer treatment which avoids some of the individualized manufacturing headaches associated with CAR-T. 

By Nicole Gray • March 11, 2016

Merck names new manufacturing head, replacing 12-year veteran

Sanat Chattopadhyay has more than 30 years of pharmaceutical experience and has been at Merck since 2009.

By Nicole Gray • March 10, 2016

Senate bill adding Zika to priority review program highlights R&D incentives

The tropical disease priority review program has been criticized for creating the wrong incentives for drugmakers. 

By Ned Pagliarulo • March 10, 2016

French regulator halts manufacturing at HIV-focused biotech

A November inspection by ANSM turned up 45 manufacturing deficiencies, including five critical flaws. 

By Nicole Gray • March 10, 2016

Counterfeit Harvoni from India found in Israel

Flagged by Swissmedic, the fake drugs were imported through a Swiss trading firm. 

By Nicole Gray • March 8, 2016

Kite, Juno ramping up commercial manufacturing capacity for CAR-T

Both companies expect to generate clinical data on their respective CAR-T therapies sometime in late 2016.

By Ned Pagliarulo • March 3, 2016

Canada's Katz hands over Rexall Health to McKesson for $2.2B

As part of the deal, McKesson will also acquire Rexall Health's 470 retail pharmacies throughout Canada. 

By Shalina Chatlani • March 3, 2016

In major expansion, Lupin subsidiary setting up plant in Japan

Lupin's subsidiary Kyowa is setting up a manufacturing plant in Tottori, to feed the growing demand for generics in Japan, where generics currently represent 49% of drug sales volume. 

By Nicole Gray • March 3, 2016

BMJ study: Single dose vials cost nearly $2B a year in wasted cancer drugs

Although packaged in single-dose vials, the drugs are typically administered based on patient body weight, leading to leftover medicine which is often discarded. 

By Nicole Gray • March 3, 2016

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