Breaking News on Global Pharmaceutical Technology & Manufacturing

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Amgen to slash 23% of its manufacturing footprint and 2,900 US jobs

Amgen to slash 23% of its manufacturing footprint and 2,900 US jobs

Amgen is slashing 15% of its workforce and closing two US manufacturing facilities as part of a restructure the firm says will save $700m (€520m) a year.

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News in brief

Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.

Zhejiang Jiuzhou Pharmaceutical has received an FDA warning letter after shipping a misbranded active pharmaceutical ingredient to the US.

Reckitt Benckiser’ opioid addiction drug Suboxone delivered by sublingual film has shown a 'surprising' level of resilience against generic competition, the firm says as it plans to spin-out its pharmaceutical business.

Robust quality systems differentiate Biocon from other Indian manufacturers, the firm says, despite political turmoil in the Middle East and North Africa impacting first quarter 2015 sales.

Global Industry News

Medidata sees revenue growth in Q2 as new clients spike from Outsourcing-Pharma.com

Cloud-based solutions provider Medidata saw its revenue increase 22% over Q2 last year to $83.2m as the company’s customer base saw steep growth.

As Ebola virus rages, funding is the main constraint for new treatments, scientist says from BioPharma-Reporter.com

The worst Ebola virus outbreak in history continues to spread in West Africa as biopharma companies are hampered by funding issues in trying to bring treatments and vaccines to human trials, a scientist says.

Where are tomorrow’s biosimilar hotspots? from BioPharma-Reporter.com

As the US FDA (Food and Drug Administration)’s biosimilars pathway is tested for the first time following Sandoz’s filgrastim submission last week, an expert predicts imminent biosimilars submissions from Celltrion and Hospira.

PaxVax acquires typhoid vaccine, Swiss manufacturing facility from BioPharma-Reporter.com

Specialty vaccine company PaxVax has acquired the oral typhoid vaccine Vivotif from Crucell, as well as its manufacturing facility in Thörishaus, Switzerland. Financial terms of the transaction were not disclosed.

Boehringer Ingelheim forges $395m peptide deal with Zealand from BioPharma-Reporter.com

Boehringer Ingelheim has entered a collaboration to develop a peptide candidate for cardio-metabolic diseases in a deal that could net partner Zealand Pharma up to €295m ($395m).

German biopharma ARTES follows GSK’s malaria vaccine announcement from BioPharma-Reporter.com

The German biopharmaceutical company ARTES has announced it is developing a malaria vaccine with Australian non-profit the Burnet Institute.

Spotlight

G-CON: Pfizer investment an endorsement of 'podular' manufacturing

Pfizer investment an endorsement of 'podular' manufacturing, says G-CON

G-CON says a multi-million dollar investment by Pfizer could hasten the “paradigm shift” in pharma manufacturing towards...

US FDA enforcement evolving in India will drive compliance costs

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and...

Ease regulations to cure drug industry antibiotic resistance, says RPS

Ease regulations to cure drug industry antibiotic resistance, says RPS

The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College,...

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix has modified its much-debated painkiller Zohydro with abuse-deterrent formulations.

Afrezza approval: Validation for Mannkind's drug and delivery tech

Afrezza approval: US FDA validation for Mannkind's drug and delivery tech

The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry...

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