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Tech transfer: The starting point for full digital transformation

(Article)

The solution to maximizing speed, accuracy and cost-efficiency is to digitize tech transfer across the entire product lifecycle

Jury awards man $8B for claims a J&J drug made him grow breasts

(News)

A Philadelphia jury has ordered Johnson & Johnson to pay a whopping $8 billion for a claim that the company failed to warn patients about serious side effects associated with an anti-psychotic drug.

Clinuvel cinches FDA nod for rare skin disease drug

(News)

For the first time ever, patients in the U.S. with a rare but painful skin disease will have access to an FDA-approved treatment.

How to find the right CDMO partner in pharma

(Article)

Taking into account the hundreds of pharmaceutical CDMOs out there to choose from, picking the right CDMO can quickly become a daunting task. The good news is there are a couple of deciding factors that remain constant industry wide.

Arizona backtracks on Purdue opioid settlement

(News)

Last month 24 states and local governments reached a deal that was speculated to be worth more than $10 billion.

Novartis blockbuster eye med wins FDA approval

(News)

Beovu injections treat wet age-related macular degeneration that affects 20 million people worldwide, according to the company.

Gilead gets 2nd HIV drug approved for PrEP

(News)

The U.S. FDA approved Gilead Sciences' Descovy for pre-exposure prophylaxis, or PrEP, among male adults and adolescents who are HIV-negative and considered to be at risk for sexually acquired HIV.

Glenmark receives FDA warning letter for Baddi plant

(News)

Mumbai-based Glenmark Pharmaceuticals has been issued an FDA warning letter for manufacturing issues at its Baddi plant.

Pfizer inks antisense drug deal worth up to $1.5B

(News)

Pfizer will front $250 million to gain rights to a phase 2 drug being developed to target a range of major diseases. Pfizer will front $250 million to gain rights to a phase 2 drug being developed to target a range of major diseases.

J&J grabs Bayer exec as new CIO

(News)

Johnson & Johnson has hired a former Bayer executive as its chief information officer.

Pharma in review: trending stories 10/4/19

(News)

pharma manufacturing news in review

Universities took millions in gifts from Sackler family

(News)

Prestigious universities around the world have accepted at least $60 million in donations over the past five years from the family that owns Purdue Pharma, even as the drugmaker became entangled in lawsuits related to the opioid epidemic.

J&J settles Ohio opioid lawsuits for $20.4M

(News)

Johnson & Johnson has agreed to a $20.4 million settlement to avoid going to trial over the opioid-addiction crisis in two Ohio counties.

Pharma's 2019 Influential Women in Manufacturing

(Article)

Two standout industry leaders from this year's class of honorees

FDA determines toxicity levels in ranitidine ‘unacceptable’

(News)

The FDA has changed its story on whether or not the levels of a possible carcinogen in ranitidine are too high.

Trump almost ready to nominate next FDA commish

(News)

The Trump administration is reportedly getting set to nominate a new FDA commissioner

How Novartis’ data manipulation case is a cautionary tale for transparency

(Article)

“Seeing something and saying something” can be applied to the life sciences when a lack of transparency could result in a company facing stiff regulatory action.

FDA rejects AZ lung disease treatment

(News)

AstraZeneca announced that the FDA has rejected its new drug application for a chronic obstructive pulmonary disease (COPD) therapy.

Endo drops FDA compounding lawsuit

(News)

Endo International announced that it has dropped its case against the U.S. FDA regarding the unlawful compounding of vasopressin from bulk drug substances.

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Product Focus: Signed, sealed, delivered

(Article)

Innovative packaging and labeling solutions help pharma manufacturers finish the job

Bangladesh bans ranitidine

(News)

With regulatory bodies in the U.S. and EU investigating the presence of a probable carcinogen in ranitidine, Bangladesh has placed an outright ban on the popular heartburn drug.

Novartis gets late stage win for asthma combo

(News)

Novartis announced that a Phase 3 trial of QMF149 in patients with uncontrolled asthma has met its primary endpoint.

Sanofi reportedly planning job cuts in Japan

(News)

Facing pressure to cut costs, Sanofi is reportedly looking at axing around 200 jobs in Japan.

FTC makes second request in AbbVie, Allergan deal

(News)

The U.S. Federal Trade Commission (FTC) has requested for more information from AbbVie and Allergan on their $63 billion deal.

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