Critics question Amarin fish oil study
There ’s something fishy about the positive results Amarin reported for its supplemental drug, Vascepa. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 12, 2018 Category: Pharmaceuticals Source Type: news

New CODP treatment gets FDA nod
Mylan and Theravance Biopharma have won approval for their inhalable treatment, Yupelri. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 12, 2018 Category: Pharmaceuticals Source Type: news

Nestle ups stake in food allergy drug developer
Nestle ’s health science arm will pay $98 million to raise its stake in Aimmune Therapeutics, as the drug developer prepares to submit a marketing application for its peanut allergy treatment before the end of the year. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 12, 2018 Category: Pharmaceuticals Source Type: news

Sandoz recalls China-made blood pressure drug
Novartis said its Sandoz division is recalling one lot of losartan tablets after finding traces of a probable carcinogen in the blood pressure drug. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 12, 2018 Category: Pharmaceuticals Source Type: news

Sandoz abandons Rituxan biosim in U.S.
Sandoz announced that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 9, 2018 Category: Pharmaceuticals Source Type: news

Philanthropist donates $200M towards Harvard biomedical science
A foundation headed by philanthropist Len Blavatnik has given Harvard Medical School its largest gift, $200 million, with the overarching aim of transforming new medical discoveries into patient treatments. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 9, 2018 Category: Pharmaceuticals Source Type: news

AbbVie sues England ’s NHS
Abbvie is claiming England's National Health Service (NHS) breached procurement rules during the process of seeking suppliers for hepatitis C treatment. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 9, 2018 Category: Pharmaceuticals Source Type: news

BMS gets ready to layoff employees, shutter operations at ZymoGenetics facility
Operations at Seattle-based ZymoGenetics, which is owned by Bristol-Myers Squibb, has been winding down for the last few years. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 7, 2018 Category: Pharmaceuticals Source Type: news

Experimental drug for rosacea meets late-stage goals
Foamix announced positive results this week for its new treatment for a common skin problem. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 7, 2018 Category: Pharmaceuticals Source Type: news

QbD and Drug Packaging and Delivery: A Guide to Creating Safer Components
The increase in injectable biologic and biosimilar treatments is requiring a stronger focus on quality requirements with respect to how the drugs are packaged and delivered. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 7, 2018 Category: Pharmaceuticals Source Type: news

AstraZeneca sells 3 more drugs for $350 million
Covis Pharma will pay AstraZeneca $350 million for rights to Alvesco, Omnaris and Zetonna which are three older drugs for asthma and rhinitis (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 6, 2018 Category: Pharmaceuticals Source Type: news

FDA slaps Akorn plant with Form 483
The regulatory body found issues at the drugmaker's New Jersey site, detailing 11 observations from an inspection in July and August. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 6, 2018 Category: Pharmaceuticals Source Type: news

Pharma ’s Latest Headache: Including Drug Prices in TV Ads
Drug companies, which have learned to live with advertisements calling out a litany of possible side effects for their drugs, may want to take a couple of aspirin. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 5, 2018 Category: Pharmaceuticals Source Type: news

Novartis scraps U.S. filing for biosimilar rituximab
Novartis International AG ’s Sandoz division will abandon its quest to win U.S. approval for rituximab. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 5, 2018 Category: Pharmaceuticals Source Type: news

Allergan axes expansion plans in Texas
Allergan has reallocated $200 million it had slated for a facility expansion in Waco, Tx. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 5, 2018 Category: Pharmaceuticals Source Type: news

The Future of Capsule Supply Chain Analytics
How and why companies should focus on leveraging data and analytics to integrate supply chains (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 5, 2018 Category: Pharmaceuticals Source Type: news

Lilly's diabetes blockbuster reduced heart risks in trial
Eli Lilly said its top-selling diabetes drug, Trulicity, significantly reduced the risk of heart attack, stroke and heart-related death in a broad range of people with type 2 diabetes, according to results of a large late-stage clinical trial. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 5, 2018 Category: Pharmaceuticals Source Type: news

FDA approves controversial potent opioid
The U.S. FDA has approved AcelRx Pharmaceuticals ’ Dsuvia sublingual tablet for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 5, 2018 Category: Pharmaceuticals Source Type: news

Proactive Roof Asset Management
Why roof preservation matters for pharma manufacturing facilities and how to best preserve roof life. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 2, 2018 Category: Pharmaceuticals Source Type: news

FDA panel says no to Alkermes depression pill
An advisory panel to the U.S. FDA voted against approving Alkermes ’ treatment for depression in patients with an inadequate response to standard antidepressant therapies. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 2, 2018 Category: Pharmaceuticals Source Type: news

Pfizer may sell women ’s health biz
Pfizer is considering the sale of its women ’s health portfolio as the drugmaker looks to focus on developing treatments with higher growth potential, according to Bloomberg sources. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 1, 2018 Category: Pharmaceuticals Source Type: news

Two former drug executives headed to prison
Former executives from Valeant Pharmaceuticals International and Philidor Rx Services have been sentenced to jail time for a secret kickback scheme. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 31, 2018 Category: Pharmaceuticals Source Type: news

Scientists make discovery they believe could lead to full-proof cancer treatment
A team of researchers at Northwestern University have discovered a kill code embedded in every cell in the body that ’s designed to combat cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 31, 2018 Category: Pharmaceuticals Source Type: news

AstraZeneca sells drug rights for $815 million
The company will divest rights to Nexium in Europe and the global rights to Vimovo to Gr ünenthal (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 30, 2018 Category: Pharmaceuticals Source Type: news

Glenmark Pharmaceuticals opens first U.S. manufacturing site
The India-based drugmaker invested more than $100 million into the Monroe, North Carolina facility that is designed to manufacture a variety of fixed dose pharmaceutical formulations (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 30, 2018 Category: Pharmaceuticals Source Type: news

What are you Afraid Of?
Pharma needs to kick open the closet and confront its digital demons (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 30, 2018 Category: Pharmaceuticals Source Type: news

Thrills and Pills: Another Top 5 Scary Pharma Flicks
It ’s that time of year when watching a movie means snuggling up to a blood-curdling tale will that make you want to hide under the covers. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 29, 2018 Category: Pharmaceuticals Source Type: news

FDA approves first-of-its-kind flu drug
For the first time in almost 20 years, the FDA has approved a new treatment for the flu. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 29, 2018 Category: Pharmaceuticals Source Type: news

Aspen announces ‘single biggest pharma investment’ in South African history
Aspen Pharmacare, South Africa ’s largest pharma company, has announced that it is pouring $235 million into its Port Elizabeth site. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 29, 2018 Category: Pharmaceuticals Source Type: news

Eli Lilly bets $100M on gene-silencing technology
Eli Lilly is spending $100 million for a stake in Cambridge-based Dicerna Pharmaceuticals as part of a licensing deal to gain access to the biotech's gene-silencing technology. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 29, 2018 Category: Pharmaceuticals Source Type: news

Takeda may divest Shire pipeline drug to clear EU hurdles
(Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 29, 2018 Category: Pharmaceuticals Source Type: news

NICE rejects AbbVie leukemia drug over price
NICE gave a negative opinion on AbbVie ’s Venclyxta in combination with Roche’s Rituxan, for treating relapsed or refractory chronic lymphocytic leukaemia in adults. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 26, 2018 Category: Pharmaceuticals Source Type: news

Amgen cuts Repatha price by 60 percent
Amgen has cut the U.S. list price of potent cholesterol drug Repatha by 60 percent to $5,850. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 26, 2018 Category: Pharmaceuticals Source Type: news

Trump proposes “revolutionary” Medicare model
In today ’s speech at the Department of Health and Human Services, President Trump proposed an " international pricing index " that would be used as a reference point for helping set prices for drugs paid for through Medicare Part B — a change the President calls “revolutionary.” (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 25, 2018 Category: Pharmaceuticals Source Type: news

Dealing with Pharma's Digital Demons
To advance, pharma must confront its digital transformation fears head-on (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 24, 2018 Category: Pharmaceuticals Source Type: news

Bayer, Orion drug shown to keep spread of prostate cancer in check
Bayer and Orion announced a major trial win this week, after a study showed that a drug the companies are developing can delay the spread of prostate cancer. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 24, 2018 Category: Pharmaceuticals Source Type: news

Biogen wins appeal for patent protection of blockbuster drug
Forward Pharma ’s challenge to Biogen’s patent on its blockbuster multiple sclerosis medication Tecfidera has been officially thwarted. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 24, 2018 Category: Pharmaceuticals Source Type: news

Turning A Buzzword Into Exponential Impact
How data is changing pharma operations (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 23, 2018 Category: Pharmaceuticals Source Type: news

AstraZeneca expands cancer immunotherapy with Innate deal
The drugmaker is buying a 9.8 percent stake in biotech company Innate Pharma, which is run by former AstraZeneca executive Mondher Mahjoubi (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 23, 2018 Category: Pharmaceuticals Source Type: news

J & amp;J offers to buy out skincare firm for $2.1 billion
The acquisition of Japanese skincare firm Ci:z Holdings will include the its range of brands comprising Dr.Ci:Labo, Labo Labo and Genomer line of skincare products (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 23, 2018 Category: Pharmaceuticals Source Type: news

FDA mulls approval for opioid 500 times stronger than morphine
An FDA committee has recommended approval of a new synthetic opioid much stronger than other pain killers on the market. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 22, 2018 Category: Pharmaceuticals Source Type: news

Merck KGaA looks for partnership deals to finance drug development
Merck KGaA could soon be announcing new partnership deals to help finance its promising drug development pipeline. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 22, 2018 Category: Pharmaceuticals Source Type: news

FDA delays approval for BMS cancer therapy
Bristol-Myers said the marketing application submitted to the U.S. FDA for its Opdivo plus Yervoy cancer therapy combination will be delayed by three months, until May 2019. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 22, 2018 Category: Pharmaceuticals Source Type: news

AstraZeneca sees strong ovarian cancer trial results
AstraZeneca ’s Lynparza greatly reduced the risk of ovarian cancer worsening in a phase III trial, helping the drugmaker take the lead against two U.S. rivals in the same class. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 22, 2018 Category: Pharmaceuticals Source Type: news

What Are You Afraid Of, Pharma?
Pharma needs to kick open the closet and confront its digital demons (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 19, 2018 Category: Pharmaceuticals Source Type: news

Pharma's Influential Women in Manufacturing
Five leaders from the industry join Putman ’s inaugural class of winners (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 19, 2018 Category: Pharmaceuticals Source Type: news

Product Focus: Making the Most of Data
Using the data deluge for better decision-making on the plant floor (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 19, 2018 Category: Pharmaceuticals Source Type: news

Sanofi dengue vax gets EMA ok, despite Philippines scandal
Sanofi's dengue vaccine, Dengvaxia, has been recommended for approval in Europe by the European Medicines Agency's Committee for Medicinal Products for Human Use. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 19, 2018 Category: Pharmaceuticals Source Type: news

Dr Reddy's sells Hyderabad API unit to Neopharma
Dr Reddy's Laboratories announced that it has entered into a definitive agreement for the sale of its active pharmaceutical ingredients manufacturing business unit located in Jeedimetla, Hyderabad, to Therapiva Private Limited. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 19, 2018 Category: Pharmaceuticals Source Type: news

FDA warns Korean drugmaker for repeat violations
The U.S. FDA issued South Korea-based Hanlim Pharm a warning letter over poor aseptic practices and inadequate processes for documentation, among other violations of good manufacturing practice (GMP). (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 19, 2018 Category: Pharmaceuticals Source Type: news