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Shionogi antibiotic gets FDA ok with mortality warning

(News)

Japan's Shionogi announced the U.S. FDA has approved its new antibiotic, Fetroja, for the treatment of complicated urinary tract infections (cUTI).

Pharma in review: trending stories 11/15/19

(News)

top stories in pharma manufacturing

Teva to resume production of child cancer drug as shortage persists

(News)

Teva Pharmaceuticals announced that it will resume production of childhood cancer drug vincristine after a recent shortage.

The elephant in the biopharma classroom

(Article)

Biopharma needs to address its workforce training methods

Mylan hit with warning letter for valsartan manufacturing

(News)

The FDA sent a Mylan facility in India a warning letting for its manufacturing of APIs related to the widespread recall of blood pressure medications.

Outbreak of a deadly swine fever could trigger global heparin shortage

(News)

Heparin, one of the world’s most critical heart medications, could soon run in short supply due to an outbreak of African swine fever that’s wiped out nearly a quarter of the world’s pigs.

AZ lupus drug hits the mark in late-stage study

(News)

AstraZeneca reported positive results this week from a late-stage lupus study.

Lonza CEO makes sudden, surprise departure

(News)

Lonza investors were reportedly taken aback this week by the surprise announcement that the company’s CEO is planning to step down.

Lupin offloads Japanese subsidiary for $526 million

(News)

The company's subsidiary Nanomi B.V. will divest its entire 99.82% stake to private equity fund Unison, which has experience in the healthcare sector.

Sandoz scoops up Aspen operations and assets in Japan for $330 million

(News)

According to the Novartis subsidiary, this acquisition reinforces its strategy to focus on Japan.

How did the FDA do in 2019? Tell us what you think!

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Take our ultra quick survey for a chance to be quoted in our December issue.

FDA hands 3rd denial to Lipocine testosterone med

(News)

The third time was not the charm for Lipocine’s male sex hormone treatment.

Roche closer to breaking into lucrative SMA market with positive trial results

(News)

Positive trial results for an oral drug to treat spinal muscular atrophy (SMA) are bringing Roche one step closer to breaking into the high-cost treatment area.

Aurobindo-Sandoz deal pushed back as FTC seeks more info

(News)

The deal, originally announced back in September 2018, will not be closed until February 2020 at the earliest.

Purdue shielded from litigation until April

(News)

A U.S. bankruptcy judge will approve an order that will extend a stay on more than 2,600 lawsuits that accuse the company and its owners of fueling the opioid crisis.

Pharma in review: trending stories 11/8/19

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AstraZeneca invests $1 billion in China

(News)

The British drugmaker is launching a fund with China International Capital Corporation and will also begin distributing Sun Pharma cancer drugs in China.

Takeda sells portfolio of drugs for $660 million to German company

(News)

The German Stada will acquire a portfolio of approximately 20 selected OTC and prescription pharmaceutical products in Russia, Georgia and CIS countries.

FDA says ranitidine no more dangerous than ‘smoked meats’

(News)

Since all the hoopla surrounding ranitidine began, the FDA has been cautious in giving a final word on how dangerous the levels of NDMA in the drug could be.

Novartis finally wins US approval for its generic Neulasta

(News)

The drugmaker's biosimilar Ziextenzo hopes to help cancer patients boost infection-fighting white blood cells during chemotherapy.

Thermo Fisher invests $24 million in biologics site in Scotland

(News)

The site expansion in Inchinnan, which aims to add large-volume liquid manufacturing capacity for cell culture media, is expected to be completed by June 2021

China OKs first new drug for Alzheimer’s in 17 years

(News)

China’s regulatory authority has approved a new treatment for Alzheimer’s based on seaweed.

J&J says recalled talc had no asbestos, negating its own expert

(News)

Johnson & Johnson said that new testing of the recently recalled batch of baby powder did not show any traces of asbestos.

Trump nominates new FDA commish as interim deadline expires

(News)

President Trump formally announced his intention to nominate Dr. Stephen M. Hahn, a top executive at The University of Texas M.D. Anderson Cancer Center, to be the next commissioner of the U.S. FDA.

Product Focus: Manufacturing meets Industry 4.0

(Article)

From increased connectivity throughout operations to better data analysis and automation tools, vendors have innovated solutions to transform every stage of production.

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