The first drug to treat smallpox wins FDA approval
Concerns that smallpox could be used as a biological weapon have now led to the first-ever approval of a drug to fight the disease. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 16, 2018 Category: Pharmaceuticals Source Type: news

FDA recalls heart drug due to contaminant linked to cancer
The FDA has issued a voluntary recall of a commonly used heart medicine due to the presence of an impurity linked to cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 16, 2018 Category: Pharmaceuticals Source Type: news

Aurobindo to acquire Apotex European ops
India ’s Aurobindo Pharma will acquire the commercial operations and certain supporting infrastructure of Canadian pharmaceutical firm Apotex International in five European countries. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 16, 2018 Category: Pharmaceuticals Source Type: news

Teva to move U.S. HQ to NJ, hire 800+
Teva Pharmaceuticals will relocate its U.S. headquarters to Parsippany, NJ in exchange for $40 million in tax credits from the state. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 16, 2018 Category: Pharmaceuticals Source Type: news

The Clock is Ticking: How to Speed up Efforts to Meet Traceability Deadlines
Digitization will require significant investment but will pay off in protection from counterfeits, cheaper recalls and improved production and inventory management (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 13, 2018 Category: Pharmaceuticals Source Type: news

Bringing Smart Instrumentation to Life Sciences
Sophisticated functionality is now available in smart instruments complying with hygienic requirements (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 13, 2018 Category: Pharmaceuticals Source Type: news

J & J loses one of the largest product-defect cases in U.S. history
Johnson& Johnson has been ordered to pay $4.69 billion to women who argued in court that its talc products contained asbestos, causing them to develop ovarian cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 13, 2018 Category: Pharmaceuticals Source Type: news

Genmab, Immatics partner on cancer immunotherapy
Germany-based Immatics Biotechnologies has entered into a research collaboration and license agreement with Danish biotech, Genmab. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 13, 2018 Category: Pharmaceuticals Source Type: news

FDA issues new gene therapy guidances
FDA ’s CBER issued a suite of six scientific guidance documents intended to serve as a framework for gene therapies. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 13, 2018 Category: Pharmaceuticals Source Type: news

After Twitter dis from Trump, Pfizer delays price hikes
Following the announcement last week that Pfizer would increase the price of dozens of drugs, President Trump took to Twitter to lambaste the company, saying that it should be “ashamed.” (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 11, 2018 Category: Pharmaceuticals Source Type: news

FDA green-lights late trials for new, non-opioid painkiller
A non-narcotic pain reliever has been given the go-ahead for late-stage trials by the FDA. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 11, 2018 Category: Pharmaceuticals Source Type: news

Former Eisai cancer exec joins Gilead
Michael Amoroso, who was a leader of Eisai's oncology group, will join Gilead's Kite as senior vice president and head of worldwide commercial, cell therapy (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 10, 2018 Category: Pharmaceuticals Source Type: news

Sanofi closes plant after pollution complaint
A federation representing local associations claimed that polluting agent emissions at Sanofi ’s Mourenx plant were 7,000 times above the legal limit (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 10, 2018 Category: Pharmaceuticals Source Type: news

Pharma ’s Reputational Tornado Zone
Companies that want to differentiate themselves need to adopt new operational and risk management defenses (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 10, 2018 Category: Pharmaceuticals Source Type: news

Amazon OTC drug sales undercuts pharmacies
The mega-company ’s line of OTC medicines is already putting pricing pressure on generic brands in pharmacies. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 9, 2018 Category: Pharmaceuticals Source Type: news

CTI cancer drug falls short in late-stage trial
A drug being developed by CTI Biopharma Corp. to treat a kind of blood cancer has failed in a late-stage trial. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 9, 2018 Category: Pharmaceuticals Source Type: news

China vows to slash cancer drug prices
Chinese government officials have vowed to speed up cuts to the cost of cancer drugs in a move that threatens revenues in the country for big drugmakers such as Eli Lilly, Roche and Novartis. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 9, 2018 Category: Pharmaceuticals Source Type: news

AbbVie wins second AndroGel liability reversal
A U.S. judge overturned a $140.1 million verdict against AbbVie in a lawsuit by a man who claimed the drugmaker misrepresented the risks of its testosterone replacement drug AndroGel. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 9, 2018 Category: Pharmaceuticals Source Type: news

API Sourcing: Your Questions Answered
Sourcing high quality APIs in a cost and time efficient manner requires a detailed understanding of manufacturing regulations and global supply chains (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 6, 2018 Category: Pharmaceuticals Source Type: news

EMA recalls drugs made with Chinese API due to cancer fears
The European Medicines Agency is recalling a number of high blood pressure and heart drugs containing an ingredient made in China after an impurity that may cause cancer was found in them. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 6, 2018 Category: Pharmaceuticals Source Type: news

Pharma execs invited to mystery Trump dinner
About 150 UK business leaders, including major pharma heads, have been invited to an undisclosed location to have dinner with President Trump. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 6, 2018 Category: Pharmaceuticals Source Type: news

Takeda looks to sell headquarters for about $542M
Japan-based Takeda Pharmaceuticals is hoping to raise more than $542 million by selling its headquarters and surrounding buildings in Osaka. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 5, 2018 Category: Pharmaceuticals Source Type: news

Less Space for Waste
As single-use technology becomes mainstream, biopharma companies need a better way to handle waste (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 2, 2018 Category: Pharmaceuticals Source Type: news

Pfizer raises price of 100 drugs
Pfizer has increased the cost of about 100 drugs including Viagra. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 2, 2018 Category: Pharmaceuticals Source Type: news

Mylan plant hit with FDA Form 483 for cleaning practices
A West Virginia plant owned by Mylan Pharmaceuticals has been issued a 32-page FDA 483 form for “numerous instances” lacking “appropriate oversight.” (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 2, 2018 Category: Pharmaceuticals Source Type: news

Roche reports good news in breast cancer combo trial
Roche announced that a Phase III trial showed its immunotherapy Tecentriq plus the chemotherapy Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 2, 2018 Category: Pharmaceuticals Source Type: news

eBook: Aseptic Processing Trends
With the rising demand of gene therapies, aseptic processing practices are changing rapidly (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 2, 2018 Category: Pharmaceuticals Source Type: news

Sanofi to open R & D hub in China
Sanofi announced plans to launch a Global R&D Operations Hub with a specialized focus on digitalization and big data analysis in Chengdu, Sichuan province, China. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 2, 2018 Category: Pharmaceuticals Source Type: news

Novartis to spin off Alcon unit
Novartis has announced its intention to spinoff Alcon, its eye care division, into a separately-traded standalone company. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 29, 2018 Category: Pharmaceuticals Source Type: news

FDA lifts clinical hold on Aptose blood cancer drug trial
Aptose Biosciences announced that the U.S. FDA has lifted the clinical hold on APTO-253, Aptose ’s investigational drug for hematologic cancers. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 29, 2018 Category: Pharmaceuticals Source Type: news

Amazon to buy online pharmacy
Amazon has announced that it will be buying the venture capital-backed startup, PillPack. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 28, 2018 Category: Pharmaceuticals Source Type: news

Vendor Selection and Management From a Small Pharma Perspective
Selecting the right vendor is critical for young companies. Here are six essential steps for making sure your company makes the right choice. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 28, 2018 Category: Pharmaceuticals Source Type: news

eBook: Solid Dose 2018
Despite the increasing number of injectable biologics, solid dose products are a proven pharmaceutical market mainstay. According to GoodRx data, the top 10 drugs based on monthly prescription volume in the U.S. are solid dosages. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 28, 2018 Category: Pharmaceuticals Source Type: news

Failed study could spell doom for Aquinox drug
Aquinox Pharmaceuticals announced this week that it is ending a study into the company ’s lead drug after disappointing results. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 27, 2018 Category: Pharmaceuticals Source Type: news

Report: Spectrum Pharma looking for buyer
Amid a wave of mergers and acquisitions in the biotech industry, Spectrum Pharmaceuticals is reportedly looking to be sold. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 27, 2018 Category: Pharmaceuticals Source Type: news

Puma Biotech breast cancer drug likely approved in Europe after reexamination
A committee of the European Medicines Agency is likely to approve the drug, five months after regulators recommended against approval (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 26, 2018 Category: Pharmaceuticals Source Type: news

Roche gets priority review for first one-time, single-dose flu drug in the U.S.
The Roche subsidiary Genentech and its baloxavir marboxil treatment could be first oral, single-dose antiviral and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 26, 2018 Category: Pharmaceuticals Source Type: news

Supply Chain Strategies for New Therapies
Autologous engineered T-cell therapies challenge traditional late stage and commercial pharma supply chains practices (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 26, 2018 Category: Pharmaceuticals Source Type: news

FDA makes first-ever approval of cannabis-based drug
For the first time ever, the FDA has approved a drug derived from marijuana. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 25, 2018 Category: Pharmaceuticals Source Type: news

Venture fund raises $350 million to fight dementia
A group of drug companies and donors recently raised more than they expected to aid the search for new drugs to combat dementia. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 25, 2018 Category: Pharmaceuticals Source Type: news

Roche sees positive data in lung cancer immunotherapy first
Roche announced positive survival data in a trial that the drugmaker hopes will yield the first immunotherapy cocktail to be approved as an initial treatment for an aggressive form of lung cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 25, 2018 Category: Pharmaceuticals Source Type: news

Merrimack halts pancreatic cancer trial
Merrimack Pharmaceuticals announced it will discontinue the development of an experimental treatment for pancreatic cancer after the drug failed to meet the main and secondary goals of a mid-stage trial. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 25, 2018 Category: Pharmaceuticals Source Type: news

More evidence for autism blood tests
One year after researchers published work on a physiological test for autism, a follow-up study confirmed its accuracy in assessing whether a child is on the autism spectrum. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 22, 2018 Category: Pharmaceuticals Source Type: news

GSK vs. Gilead in AIDS treatment race
GlaxoSmithKline and Gilead Sciences will be showcasing rival strategies for fighting the AIDS virus at next month ’s global AIDS conference. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 22, 2018 Category: Pharmaceuticals Source Type: news

The ‘Blueprint’ to Control Drug Prices: A Quick Guide for Manufacturers
With regulatory measures related to drug prices and rebates supported by both sides of Congress, manufacturers should be prepared for new challenges. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 21, 2018 Category: Pharmaceuticals Source Type: news

Ex-Puma Biotech exec gets prison term
Former Puma Biotechnology executive, Robert Gadimian, was sentenced to prison for illegally trading on inside information about a breast cancer drug. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 21, 2018 Category: Pharmaceuticals Source Type: news

Facing pressure from Amazon, CVS launches prescription delivery service
Since the news broke that Amazon could enter the prescription drug distribution business, rumors have run rampant about how that move will impact the pharma industry. But CVS Health isn ’t waiting to find out. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 20, 2018 Category: Pharmaceuticals Source Type: news

Purdue axes remaining sales force as legal troubles mount
With an avalanche of opioid-related lawsuits piling onto Purdue Pharma, the maker of OxyContin has laid off 350 employees. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 20, 2018 Category: Pharmaceuticals Source Type: news

Personalization Status: It ’s Complicated
In the 10 days following the news about Facebook ’s data privacy breach involving political consultancy, Cambridge Analytica, Facebook shares dropped almost 18 percent. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 19, 2018 Category: Pharmaceuticals Source Type: news

Sanofi names former automaker exec as CFO replacement
Jean-Baptiste Chasseloup de Chatillon, who most recently served as CFO of PSA Group, will join Sanofi in September. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 19, 2018 Category: Pharmaceuticals Source Type: news