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FDA Gathers Faster Drug Data
FDA implements initiatives to speed drug approvals, labeling changes and delivery (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 30, 2017 Category: Pharmaceuticals Source Type: news

Merck Offers Candid Details on Pricing Practices
Merck has published a report outlining the company's average list price increases for its products, as the industry deals with widespread pricing criticism. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 30, 2017 Category: Pharmaceuticals Source Type: news

Amgen Gets EMA Ok for Humira Biosims
The European Medicines Agency (EMA) recommended the approval of two Amgen biosimilars for AbbVie ’s blockbuster Humira, for treatment of inflammatory diseases. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 28, 2017 Category: Pharmaceuticals Source Type: news

Pharma'Bad Boy' Shkreli Attacks Pharma Trade Group
The former Turing Pharma exec touts a website exposing industry wrong-doings, after a trade group launches ad campaign that aims to distance the industry from him (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 27, 2017 Category: Pharmaceuticals Source Type: news

J & J Spends $30B on Actelion Rare Disease Portfolio
As part of the transaction, Actelion will spin out its drug discovery operations and early-stage clinical development assets into a newly created Swiss biopharmaceutical company (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 27, 2017 Category: Pharmaceuticals Source Type: news

Endo Restructures, Eliminates 90 Jobs
Endo International will cut 90 full-time positions, including 45 at its Malvern, Pennsylvania, headquarters (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 27, 2017 Category: Pharmaceuticals Source Type: news

Electronic Batch Records: Improving Compliance, Accelerating Time to Market
An electronic batch record solution that is integrated with enterprise information systems improves compliance and streamlines the creation of batch records so products can be delivered to market more quickly (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 27, 2017 Category: Pharmaceuticals Source Type: news

Streamlining Single-Use Processing on a Global Scale
Harmonization across global single-use processing operations delivers the efficiencies, cost savings and quality critical for success (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 27, 2017 Category: Pharmaceuticals Source Type: news

Spray Drying Enhances Solubility and Bioavailability
Regulatory approval of the first aseptically spray-dried drug validates this newer technology (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 26, 2017 Category: Pharmaceuticals Source Type: news

Jazz Pharma Supplier Facility Hit with FDA Warning
Jazz Pharmaceuticals'CDMO -- UK-based Porton Biopharma -- received a Warning Letter from the FDA regarding cGMP violations noted during an on-site inspection. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 26, 2017 Category: Pharmaceuticals Source Type: news

Serious Concerns Raised Over Safety of New Hep C Drugs
Report from non-profit Institute for Safe Medication Practices finds that new treatments may have severe side effects, including liver failure (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 25, 2017 Category: Pharmaceuticals Source Type: news

India's Cadila/Zydus Acquire Eight AZ Brands
AstraZeneca has divested its brands in anti-infective and women ’s health portfolio to Zydus Healthcare in order to focus on its primary therapy areas (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 24, 2017 Category: Pharmaceuticals Source Type: news

Merck to Pay $625M Plus Royalties in BMS Lawsuit
Bristol-Myers Squibb and partner Ono Pharmaceutical settle with Merck on patent-infringement battle for anti-PD-1 therapy Keytruda (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 24, 2017 Category: Pharmaceuticals Source Type: news

The Art of the Request for Proposals
A well-written RFP and effectively managed process is well worth the upfront time and effort (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 23, 2017 Category: Pharmaceuticals Source Type: news

Supreme Court to Address its First Biosimilars Dispute
The U.S. Supreme Court recently granted cross-petitions for certiorari in Sandoz Inc. v. Amgen and Amgen Inc. v. Sandoz Inc., marking the first time in which the Supreme Court will addresses issues arising under the Biologics Price Competition and Innovation Act of 2009. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 23, 2017 Category: Pharmaceuticals Source Type: news

FDA Forms Oncology Center of Excellence
The move establishes oncology as the first disease area to have a coordinated clinical review of drugs, biologics and devices across the FDA's three medical product centers. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 23, 2017 Category: Pharmaceuticals Source Type: news

Mallinckrodt Pays $100M to Settle Price Gouging Suit
Questcor Pharmaceuticals was accused of illegally raising the price of its best-selling drug Acthar by 85,000 percent (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 22, 2017 Category: Pharmaceuticals Source Type: news

Eli Lilly to Lay Off 485 Workers
Because of an Alzheimer's drug failure, Lilly USA announced nationwide layoffs (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 22, 2017 Category: Pharmaceuticals Source Type: news

The Good, the Bad & the Donald: CPhI Worldwide's 2017 Pharma Predictions
Orphan drugs, CMO continuous manufacturing and developing world sales offer biggest revenue opportunities (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 20, 2017 Category: Pharmaceuticals Source Type: news

EpiPen Competitor Auvi-Q Re-Enters Market in February
Virgina-based Kaleo Pharma will re-introduce its competitor to Mylan's EpiPen back to the market on February 14. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 20, 2017 Category: Pharmaceuticals Source Type: news

GSK Pharma Chief Exits After Losing CEO Spot
GlaxoSmithKline's pharmaceuticals chief Abbas Hussain will be leaving the company after not being chosen to succeed outgoing Chief Executive Andrew Witty. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 19, 2017 Category: Pharmaceuticals Source Type: news

Lilly buys migraine-drug maker CoLucid Pharmaceuticals for $960M
Deal will enhance its pain management portfolio for migraine with CoLucid's in-development lasmiditan (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 19, 2017 Category: Pharmaceuticals Source Type: news

FDA Warns Japanese, Chinese Drug Makers for Violations
FDA sent warning letters to pharmaceutical makers Sato Yakuhin Kogyo Co. in Japan and Suzhou Pharmaceutical Technology Co. in China (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 19, 2017 Category: Pharmaceuticals Source Type: news

McKesson Pays $150M in Fines, Halts Drug Sales
The California-based drug distributor will pay a civil penalty of $150M and suspend sales in four states (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 18, 2017 Category: Pharmaceuticals Source Type: news

Biogen Agrees to $1.25B Deal to License Forward Pharma MS IP
The deal will give Biogen a safety net for future sales of Tecfidera, its blockbuster oral treatment that garnered $4 billion in 2016. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 17, 2017 Category: Pharmaceuticals Source Type: news

Investigation Says Drugmakers Manipulate Orphan Drug System
Drugmakers are manipulating the Orphan Drug Act -- which offers lucrative financial incentives in order to motivate pharmaceutical companies to develop rare disease drugs -- to maximize profits and to protect niche markets, says a Kaiser Health News investigation. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 17, 2017 Category: Pharmaceuticals Source Type: news

ARIAD Pharma Under Investigation in Takeda Deal
A securities firm is looking into whether ARIAD's Board of Directors breached fiduciary duties to the company's stockholders (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 17, 2017 Category: Pharmaceuticals Source Type: news

FDA Speeds Generic Drug Approvals
New FDA Draft Guidance helps define " generics " terms and offers ways to expedite bringing generic drugs to market (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 16, 2017 Category: Pharmaceuticals Source Type: news

Trump Looks Beyond Doctors in FDA Commissioner Hunt
President-elect Donald J. Trump is reportedly looking beyond traditional medical experts in his search for the new FDA commissioner, meeting with two Silicon Valley investors. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 16, 2017 Category: Pharmaceuticals Source Type: news

FDA to Rule on Merck Keytruda Combo by May
Merck& Co. announced that the U.S. FDA has accepted its application for a new Keytruda-plus-chemotherapy combo and granted the drugmaker priority review. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 16, 2017 Category: Pharmaceuticals Source Type: news

Eli Lilly Beats Teva Appeal on Generic Cancer Drug
Eli Lilly blocks Teva from selling a generic equivalent of its lung cancer drug Alimta (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 13, 2017 Category: Pharmaceuticals Source Type: news

Shire Forks Over $350M to Settle Bribery Case
Shire settles accusations that it bribed clinicians and doctors by using kickbacks to encourage the use of its bioengineered human skin substitute Dermagraft (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 13, 2017 Category: Pharmaceuticals Source Type: news

J & J, Actelion Tentatively Agree on Price
Discussions are focused on valuing what would be a new unit that would house the research and development assets (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 13, 2017 Category: Pharmaceuticals Source Type: news

Trump's Newest Biotech Attack
In yesterday's press conference, President-elect Donald Trump laid into the pharmaceutical industry, sending biotech shares plunging. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 12, 2017 Category: Pharmaceuticals Source Type: news

Valeant Sheds 3 Skin-care Brands, Dendreon for $2.1B
Cash meant to reduce its more than $30 billion debt. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 11, 2017 Category: Pharmaceuticals Source Type: news

STEERLife Collaborates with Ole Miss on Drug Development and Manufacturing Research
Move aims to develop advanced pharmaceutical applications including semi solid formulations for dermal and transdermal applications and provide solutions for the industry. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 10, 2017 Category: Pharmaceuticals Source Type: news

Wish List, Predictions for 2017
A number of quite interesting events permeated the pharma world in 2016, leading me to make some predictions for the New Year.Continuous Manufacturing (CM): This trend has been growing for several years, with some of the leaders submitting NDAs and some retrofitting batch processes to be continuous. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 10, 2017 Category: Pharmaceuticals Source Type: news

Shkreli Strikes Again, Twitter Account Suspended
Former Turing Pharma exec Martin Shkreli is accused of harassing a reporter via Twitter; CEO Jack Dorsey suspends Shkreli's account (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 10, 2017 Category: Pharmaceuticals Source Type: news

Ipsen Buys Merrimack Pancreatic Cancer Drug
Ipsen will gain commercialization rights for all ONIVYDE indications in the U.S. as well as other assets (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 10, 2017 Category: Pharmaceuticals Source Type: news

Mylan Looks to Sell EpiPen Directly to Public Places
Mylan is looking to set up its own pharmacy to cut out middlemen and enable the drugmaker to sell EpiPens directly to public places, says a Bloomberg article. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 10, 2017 Category: Pharmaceuticals Source Type: news

Takeda Seeks to Buy Cancer Drug Maker Ariad Pharma for $5.2 B
Deal comes after Japanese company ’s desire to reduce its domestic sales dependence (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 9, 2017 Category: Pharmaceuticals Source Type: news

Novartis, Ionis Pharma Collaborate on Heart Meds
Novartis invests in next generation therapies to reduce cardiovascular risk in patients with underlying lipid disorders (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 6, 2017 Category: Pharmaceuticals Source Type: news

Amgen Wins; Sanofi, Regeneron Lose Patent Case
A U.S. federal judge upheld Amgen's patents for its cholesterol drug Repatha, but Sanofi/Regeneron plan to appeal (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 6, 2017 Category: Pharmaceuticals Source Type: news

Lung Cancer Drug Demand Rises Amid China Air Pollution
Chinese pharma companies are facing a huge demand for lung cancer treatments as air pollution and high smoking rates make lung cancer the most common type of cancer in the country. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 6, 2017 Category: Pharmaceuticals Source Type: news

Roche Gets FDA Nod for 18-Minute Fertility Test
Roche received clearance from the U.S. FDA for an Anti-M üllerian (AMH) assay, making it the first approved fully automated AMH test available in the U.S. to doctors looking to help women who are struggling with infertility. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 6, 2017 Category: Pharmaceuticals Source Type: news

Lilly Reorg Brings in New Head, Execs
 Eli Lilly has announced a series of changes to its organization and leadership structure. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 6, 2017 Category: Pharmaceuticals Source Type: news

Prosecutors Raid Novartis Offices in Bribery Probe
Greek prosecutors raid Novartis'Athens offices searching for proof of bribery allegations (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 4, 2017 Category: Pharmaceuticals Source Type: news

FDA Cites Wockhardt for Multiple Violations
An inspection in its India-based manufacturing site uncovered equipment maintenance documents, raw material labels and work orders in the company ’s scrap yard (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 3, 2017 Category: Pharmaceuticals Source Type: news

Sanofi, Boehringer Ingelheim Close Business Swap
An exchange of Sanofi ’s animal health business (Merial) and Boehringer Ingelheim’s consumer healthcare (CHC) business, has been successfully closed (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 3, 2017 Category: Pharmaceuticals Source Type: news