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Amgen, Allergan launch first anti-cancer biosims in U.S.

(News)

Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.

Novartis denies wrongdoing but sets aside $700M for kickbacks lawsuit

(News)

Novartis CEO Vas Narasimhan announced that $700 million has been set aside in the hope of settling a decade-old lawsuit alleging that the Swiss drugmaker bribed U.S. doctors.

FDA accuses Indian company of shredding documents before inspection

(News)

With the FDA getting ready to knock on their door, officials at Strides Pharma Science Ltd. appear to have attempted to destroy quality-control documents.

Merck’s new antibiotic gets FDA nod

(News)

The FDA has given the go-ahead to an antibiotic developed by Merck to treat urinary tract and abdominal infections.

Gilead to build viral vector facility to strengthen cell therapy capabilities

(News)

The company's Kite Pharma subsidiary will now produce its own Yescarta viral vector material, which it had previosly been purchasing from contractors.

Novartis sickle cell med nabs accelerated FDA review

(News)

The company's crizanlizumab will receive a priority review, shortening the standard FDA process from ten months to six months.

FDA hands Eton Pharma CRL for eye drops

(News)

Eton Pharmaceuticals announced that the U.S FDA provided Eton’s partner with a Complete Response Letter relating to the application for investigational eye drops.

Gilead inks $5B deal with Galapagos to bolster pipeline of anti-inflammatories

(News)

Gilead Sciences has struck a major expansion deal with a European biotech firm to target the high-growth anti-inflammatories market.

Boehringer buys cancer vaccines biotech

(News)

Boehringer Ingelheim announced its acquisition of AMAL Therapeutics, a private Swiss biotechnology company focused on cancer immunotherapy and advancing first-in-class therapeutic cancer vaccines derived from its technology platform, KISIMA.

Report: J&J facing criminal investigation in ongoing talc scandal

(News)

The Department of Justice is reportedly investigating claims that Johnson and Johnson officials lied about cancer risks tied to its popular baby powder.

Product Focus: Advancing aseptic processing

(Article)

How the pharma industry's big ideas are impacting sterile manufacturing

Nexus Pharma to build sterile injectable facility in Wisconsin

(News)

Illinois-based Nexus Pharmaceuticals is planning a $250-million project in Wisconsin in order to build and equip a 100,000-square-foot, three-story sterile drug manufacturing facility.

Reckitt to pay $1.4B in opioid settlement

(News)

Reckitt Benckiser Group will pay up to $1.4 billion to settle U.S. investigations into whether its former pharma unit organized a multibillion-dollar fraud to drive up sales of its opioid-addiction treatment, Suboxone.

GSK HIV duo beats out standard drug-trio in new study

(News)

GlaxoSmithKline reported this week that its combo HIV treatment met its main goal in a study comparing it to a mix of three drugs.

FDA pulls 31 ANDAs from troubled generics maker

(News)

The challenges are mounting for Canadian generics drugmaker Apotex.

Novartis puts generic epinephrine shots up for sale in U.S.

(News)

The company's Sandoz unit is making its generic available to local pharmacies across the country, helping to alleviate an EpiPen shortage caused by manufacturing issues.

Fosun buys GSK plant, hepatitis B drug rights

(News)

YaoPharma, Fosun's Chongqing unit, will spend up to $36 million to buy GlaxoSmithKline's Suzhou pharmaceutical factory.

GSK opens continuous manufacturing plants

(News)

GlaxoSmithKline has opened two “state-of-the-art” facilities in Singapore with continuous manufacturing capabilities.

New bipolar depression treatment misses the mark in recent study

(News)

A new treatment being investigated for bipolar depression has failed to meet its main goal in a recent study.

Roche, Spark delay takeover deal (again)

(News)

Roche and Spark Therapeutics agreed to extend the deadline for Roche's $4.3 billion takeover bid for the U.S. gene therapy specialist.

Trump suggests executive order on drug prices, but is unclear on details

(News)

President Trump mentioned that the White House was writing an executive order to require pharma companies to offer the U.S. government lower prices — but did not elaborate on details.

Biosimilars are coming to LATAM

(Article)

There is a flourishing biosimilar industry in Latin America, with its own research, development, production and commercialization capacity.

Amicus inks gene therapy deals with Thermo Fisher and Catalent

(News)

Amicus Therapeutics has found CDMO partners to manufacture its gene therapies.

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