Class action lawsuit accuses AbbVie of creating ‘patent thicket’ for Humira
AbbVie is once again facing pressure for its alleged attempts to protect its blockbuster medication, Humira, from generics competition. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 20, 2019 Category: Pharmaceuticals Source Type: news

Novo Nordisk looks to shake up diabetes market with new pill-based treatment
Novo Nordisk has submitted an approval application for a new diabetes pill to the FDA. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 20, 2019 Category: Pharmaceuticals Source Type: news

The Highest — and Lowest — Ranked Places to Work in Big Pharma
How pharma companies fair on Glassdoor. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 20, 2019 Category: Pharmaceuticals Source Type: news

The Top 10 Highest — and Lowest — Ranked Places to Work in Pharma
How pharma companies fair on Glassdoor. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 20, 2019 Category: Pharmaceuticals Source Type: news

Pfizer invests in French gene therapy co.
Pfizer announced it has acquired a 15 percent stake in Vivet Therapeutics, with an exclusive option to fully acquire the privately-held French gene therapy company. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 20, 2019 Category: Pharmaceuticals Source Type: news

Sage Therapeutics wins first FDA postpartum approval
The U.S. FDA has approved Sage Therapeutics'Zulresso, the first drug approved by the agency specifically to treat postpartum depression. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 20, 2019 Category: Pharmaceuticals Source Type: news

Pharma's Rep: Redeeming the Seedy & Greedy
Can the pharma industry restore luster to its dimming reputation? (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 19, 2019 Category: Pharmaceuticals Source Type: news

FDA approves Roche treatment for small cell lung cancer
Roche has elbowed its way into the market of new treatments for an aggressive kind of lung cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 19, 2019 Category: Pharmaceuticals Source Type: news

Amarin defies critics with more positive Vascepa data
Amarin Corp. has released new data from a study showing that its fish oil medication, Vascepa, can significantly reduce the occurrence of several adverse heart events. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 18, 2019 Category: Pharmaceuticals Source Type: news

Pharma's Damaged Reputation
Can the industry fix its image problem? (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 18, 2019 Category: Pharmaceuticals Source Type: news

Novartis' Alcon buys PowerVision
Alcon, Novartis'eye care division, has acquired PowerVision, a privately-held medical device development company focused on creating fluid-based intraocular lens implants. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 18, 2019 Category: Pharmaceuticals Source Type: news

Prosecutors raid Korean Exchange in Samsung Bio probe
Samsung Biologics is again in the spotlight over its 2016 initial public offering as prosecutors raided the office of the Korea Exchange. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 15, 2019 Category: Pharmaceuticals Source Type: news

Generics Surge Forward
AAM Access! 2019 makes it clear that generics have earned their seat at the table (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 15, 2019 Category: Pharmaceuticals Source Type: news

Novartis Sandoz CEO steps down
Novartis has announced that Richard Francis will be stepping down as CEO of Sandoz. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 15, 2019 Category: Pharmaceuticals Source Type: news

Drugmakers join Fox News show boycotts
Several drugmakers are joining the growing group of protestors who are distancing themselves from the Fox News Channel shows featuring Tucker Carlson and Jeanine Pirro after the hosts were accused of making bigoted statements. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 15, 2019 Category: Pharmaceuticals Source Type: news

FDA warns Jubilant India plant
The U.S. FDA has issued a warning letter to Jubilant Generics for its Roorkee, North India facility. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 14, 2019 Category: Pharmaceuticals Source Type: news

eBook: Biopharma Manufacturing Trends 2019
How slow-motion trends are driving biopharma growth, the dangerous impact of unproven stem cell therapies and more. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 14, 2019 Category: Pharmaceuticals Source Type: news

Preparing for the Upsurge in Pharma Cyber Attacks
In 2019, the number of connected OT devices will continue to grow exponentially and so will the OT security threat landscape. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 14, 2019 Category: Pharmaceuticals Source Type: news

FDA combats valsartan shortage with new generic approval
As recalls widen for the popular blood pressure medication, valsartan, the FDA has approved a new generic version of the drug. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 14, 2019 Category: Pharmaceuticals Source Type: news

J & amp;J labeled the ‘kingpin’ of the opioid epidemic in Ok. lawsuit
As litigation against manufacturers involved in opioid sales continues to mount, lawyers in an Oklahoma lawsuit have taken aim at Johnson& Johnson. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 14, 2019 Category: Pharmaceuticals Source Type: news

National Cancer Institute head to act as FDA commissioner
While the search for a permanent FDA chief is still ongoing, Norman Sharpless will take over Scott Gottlieb's position in April. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 12, 2019 Category: Pharmaceuticals Source Type: news

Fujifilm buys Biogen biologics unit for $890 million
According to the Japanese company the acquisition is meant to shore up its healthcare business (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 12, 2019 Category: Pharmaceuticals Source Type: news

Martin Shkreli investigated for running pharma company from jail
The infamous “Pharma Bro” is in the hot seat again — this time for allegedly involving himself in business dealings from prison with a contraband phone. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 11, 2019 Category: Pharmaceuticals Source Type: news

Pfizer ’s Herceptin biosimilar wins FDA nod
Roche ’s blockbuster cancer treatment, Herceptin, will now face increasing competition from a new biosimilar. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 11, 2019 Category: Pharmaceuticals Source Type: news

Excipients Fit for 21st Century Medicine
DuPont's novel excipient is designed to better stabilize biologics (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 11, 2019 Category: Pharmaceuticals Source Type: news

Merck & Co inks pain drug deal with KCL, Wellcome
King ’s College London (KCL) and Wellcome Trust (a medical charity) have signed a licensing deal with Merck& Co.(MSD), that could lead to a new class of pain medications. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 11, 2019 Category: Pharmaceuticals Source Type: news

Roche grabs first breast cancer immunotherapy approval
Roche ’s Tecentriq is now the first immunotherapy drug approved by the FDA for the treatment of breast cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 11, 2019 Category: Pharmaceuticals Source Type: news

Facebook to combat anti-vax misinformation
Facebook said it will reduce the distribution of misleading medical advice about vaccines and provide people with authoritative information on the topic, as the platform works to stop the spread of anti-vaccine misinformation. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 8, 2019 Category: Pharmaceuticals Source Type: news

ViiV HIV shot passes late-stage trials
ViiV Healthcare has announced that its once-a-month shot, designed as an alternative to daily doses of HIV treatment drugs, has met primary endpoints in a pair of pivotal phase III studies. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 8, 2019 Category: Pharmaceuticals Source Type: news

4 key questions after Gottlieb ’s sudden departure
The announcement this week that FDA Commissioner, Scott Gottlieb, will be leaving his post came as a surprise to many in the industry. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 6, 2019 Category: Pharmaceuticals Source Type: news

Worrying side effects put damper on Alnylam ’s positive trial results
Alnylam Pharmaceuticals ’ new treatment for a rare disease has been shown to be effective — but analysts are now worried about its safety. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 6, 2019 Category: Pharmaceuticals Source Type: news

FDA Commissioner Gottlieb resigns
The Washington Post is reporting, citing an unnamed administration official, that U.S. Food and Drug Administration chief Scott Gottlieb will step down in about one month. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 5, 2019 Category: Pharmaceuticals Source Type: news

Second HIV patient seemingly cured, providing new hope
Following the Berlin patient ’s apparent cure announced 10 years ago, a UK patient has shown undetectable levels of HIV virus 18 months after receiving treatment (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 5, 2019 Category: Pharmaceuticals Source Type: news

The Case for Predictive Maintenance
Leveraging data will not only help pharma predict asset failures, but also eliminate them (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 5, 2019 Category: Pharmaceuticals Source Type: news

With lawsuits mounting, Purdue Pharma exploring bankruptcy
Purdue Pharma, the maker of OxyContin, could file for bankruptcy to address the nearly 2,000 lawsuits the company faces for its role in the opioid epidemic. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 5, 2019 Category: Pharmaceuticals Source Type: news

The FDA finds a third cancer-causing toxin in recalled blood pressure meds
A global recall of a commonly used blood pressure medication has widened after the FDA detected the presence of a third chemical linked to cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 5, 2019 Category: Pharmaceuticals Source Type: news

Lilly to offer authorized generic of blockbuster insulin
Eli Lilly plans to sell an authorized generic version of its blockbuster insulin, Humalog, for half the cost (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 4, 2019 Category: Pharmaceuticals Source Type: news

The Case for Outsourcing Buffer Preparation in Pharma
Why manufacturers are seeking alternative options to in-house preparation. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 4, 2019 Category: Pharmaceuticals Source Type: news

Biogen to buy gene therapy co focused on rare eye disease
Biogen has agreed to buy British gene-therapy company Nightstar Therapeutics, accelerating Biogen's entry into the emerging growth area of eye diseases. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 4, 2019 Category: Pharmaceuticals Source Type: news

Philippines DOJ to indict Sanofi employees over vax deaths
The Philippine Department of Justice said it will indict employees from Sanofi and former and current Philippine health officials over a series of deaths related to the French drugmaker's dengue vaccine. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 1, 2019 Category: Pharmaceuticals Source Type: news

FDA hands Akorn its fourth 483
The FDA has issued Akorn a Form 483, following an inspection of the drugmaker's manufacturing plant in New York, just weeks after Akorn received a warning letter for its Illinois site. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - March 1, 2019 Category: Pharmaceuticals Source Type: news

Cohen: Novartis wanted access to the president
In a bombshell testimony before Congress, President Trump ’s ex-lawyer Michael Cohen described the details of a deal he made with Novartis, which wanted him to lobby for the company and provide access to the White House. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 27, 2019 Category: Pharmaceuticals Source Type: news

Merck KGaA makes a $5.9B play for Versum
Merck and Co. is attempting to woo Versum Materials away from its already announced merger deal with Entegris. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 27, 2019 Category: Pharmaceuticals Source Type: news

Merck makes a $5.9B play for Versum
Merck and Co. is attempting to woo Versum Materials away from its already announced merger deal with Entegris. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 27, 2019 Category: Pharmaceuticals Source Type: news

No-Compromise Cold Chains
Exploring the benefits of cold-chain-as-a-service (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 27, 2019 Category: Pharmaceuticals Source Type: news

US senators blast drug company execs over pricing practices
Executives from seven of the largest drug companies testified before Congress to discuss drug costs. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 26, 2019 Category: Pharmaceuticals Source Type: news

FDA warns of blood clots and death associated with higher dose of Pfizer's Xeljanz
A safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of the drug was used in patients with rheumatoid arthritis. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 26, 2019 Category: Pharmaceuticals Source Type: news

Why the surge in generics approvals hasn ’t lowered drug prices
In the last few years, the FDA has touted its efforts to bring more generic drugs onto the market as a strategy to lower drug prices. But payoff may not be as large as the agency had hoped. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 25, 2019 Category: Pharmaceuticals Source Type: news

GE sells biopharma unit in major $21.4B deal
In an effort to return to its industrial roots, General Electric has sold its biopharmaceutical business to Danahar Corp. for $21.4 billion. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 25, 2019 Category: Pharmaceuticals Source Type: news

Spotlight on Data Integrity
How laboratory information management systems are helping pharma stay compliant (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 25, 2019 Category: Pharmaceuticals Source Type: news