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Perfecting CAPA

(Article)

Quality & Compliance: “Flawless” may not exist on the plant floor, but reviewing your quality process can save money and lives.

European regulators won't back Amgen/UCB drug

(News)

Amgen and Belgian partners at UCB announced that the EMA has adopted a negative opinion on Evenity, for the treatment of osteoporosis in men and in postmenopausal women at increased risk of fracture.

Retrofitting batch with single-use

(Article)

Automation & Control: Single-use technologies offer multiple benefits for those who can overcome instrumentation challenges.

eBook: Generic Drugs 2019

(Whitepaper)

Biosimilar commercialization challenges, real-world tips for updating aging facilities and a deep dive into interchangeability guidance.

CDMO trends: Drug development and industry consolidation

(Article)

How those in the outsourcing sector can be more prepared to meet shifting customer demands as the industry continues to evolve.

Novartis gets tangled in chemical weapons controversy

(News)

Critics have taken aim at Novartis for its ties to a company that bought APIs in Syria that could have been used to make chemical weapons.

New approval for Dupixent could help propel it to blockbuster status

(News)

The FDA has given Dupixent the go-ahead as a treatment for nasal polyps.

FDA DSCSA Pilot Project Program

(Article)

A Q&A about the FDA DSCSA Pilot Program Pilot

AbbVie buys Allergan for $63 billion

(News)

The newly combined company will be led by Abbvie chairman and CEO Richard Gonzalez.

Akorn hit with yet another FDA warning letter

(News)

The warning letter is the result of an inspection of the company’s Somerset, New Jersey-based plant in July and August 2018.

A dose of Washington comes to CPhI in Chicago

(Article)

CPhI N. America's keynote speaker explains what bipartisan bickering means for pharma

Modernizing manufacturing through a connected shop floor

(Article)

Eliminating siloed systems in favor of streamlined applications allows for greater agility and stronger collaboration, enabling pharma to meet the new quality management demands

Joint ventures in pharma (and nature)

(Article)

Shared pursuits might lead to bigger rewards

FDA Oks new female libido drug

(News)

The FDA has approved a new medication created to treat hypoactive sexual desire disorder in premenopausal women.

Opdivo misses the mark in head-to-head liver cancer trial

(News)

Bristol-Myers Squibb’s efforts to increase treatment indications for its immunotherapy blockbuster, Opdivo, have hit a bump in the road.

Sun Pharma hit with Form 483 for Halol facility

(News)

Sun Pharmaceutical said it has received four observations from the U.S. FDA for its Halol facility in Gujarat.

FDA rejects Daiichi Sankyo's blood cancer treatment

(News)

Just days after receiving approval in Japan, Daiichi Sankyo said the U.S. FDA will not approve its drug, quizartinib, as a treatment for adults with a type of blood cancer.

Pharma's budding opportunity

(Article)

Why the industry is forming bonds with CBD

GSK wants to sell consumer health drugs for $1.2 billion

(News)

As GlaxoSmithKline readies a spin-off of its consumer healthcare business, the company is looking to shed certain parts of its portfolio.

Merck begins hunt for new CEO

(News)

Merck and Co. is scouting for a replacement for its CEO, Kenneth Frazier.

Pharmacy flags another valsartan impurity, argues FDA limits are too high

(News)

Online pharmacy Valisure reported that it found a new carcinogenic impurity in some lots of blood pressure medicine valsartan, but the amount is still well below levels the FDA deemed potentially harmful.

Roche personalized cancer drug Rozlytrek nabs first approval

(News)

Japan is the first country to approve the drug, which targets patients with NTRK fusion-positive solid tumors, across 10 different tumor types.

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