- Novartis unit teams up with medical marijuana producer, marking milestone for pharma (statnews.com)
Medical marijuana has stepped onto the global stage...In what appears to be a first for marijuana and a major pharmaceutical company, a Novartis subsidiary and a Canadian producer of medical cannabis products have agreed to market them around the world...Tilray Canada announced the agreement...Under the deal...Tilray and Sandoz will work together to supply and distribute non-smokable medical cannabis products (co-branding eight oil and capsule medical cannabis products)...the two companies will target. Tilray now sells its products in 12 countries and has operations in Canada, Australia, New Zealand, Germany, Portugal, and Latin America...
- Can blockchain stem the tide of counterfeit drugs in India? (pharmaceutical-technology.com)Blockchain use case: Healthcare supply chain (healthcareitnews.com)
The manufacture and distribution of fake prescription drugs is a global problem. Counterfeit products are causing a lot of damage to economies, industries, consumer health and safety. From the perspective of companies, they know they will suffer revenue and reputational losses whilst also incurring extra expenses for regulations, brand protection and legal advice if a solution to counterfeit drugs is not found...Now, an international partnership is bringing together IT giant Oracle, policy institute NITI Aayog, Apollo Hospitals and pharma manufacturer Strides Pharma Sciences to pilot a pioneering drug supply chain using blockchain digital ledger technology to try and tackle the issue...How can blockchain help companies to counter counterfeiters?...can this digital approach succeed where other anti-counterfeiting measures have failed?
- This Week in Managed Care: December 14, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Is China the next great hope for the pharma industry? (pharmaceutical-technology.com)
Many top pharma firms have been forced to drop prices to get a slice of the Chinese market, but that hasn’t dampened spirits one bit – on the contrary, CEOs from companies like AstraZeneca and Pfizer have been celebrating dramatic Chinese sales increases in 2018. So how is China’s pharmaceutical market growing and is it really a clean bill of health for any internationals lining up to profit?...In pharmaceuticals specifically, China is comfortably the second-largest national market in the world, with healthcare analytics firm Iqvia putting its value at $122.6bn in 2017 and projecting growth to as much as $175bn by 2022...Multinational pharma firms are starting to make China a major priority for drug sales, as the potential for profit is now widely seen as a decisive counterbalance against the risks of operating under the Chinese regime...So what does China mean to the international pharma industry, and what opportunities and challenges are drug manufacturers encountering as they attempt to crack this lucrative market?
- Demographic changes bring opportunities
- Foreign firms are making big bets on China
- Regulatory reform opens China to foreign innovators
- Chinese competition and policy uncertainty remain a challenge
- Elizabeth Warren: It’s time to let the government manufacture generic drugs (washingtonpost.com)
Forty-seven states and the Justice Department are investigating a price-fixing conspiracy that’s driving up the cost of generic drugs in the United States. One investigator called it “most likely the largest cartel in the history of the United States.” This crisis calls for action. That is why I’m introducing legislation to authorize the public manufacture of generic drugs wherever drug companies have warped markets to drive up prices....Drug companies use the “free market” as a shield against any effort to reduce prices for families. But they’re not operating in a free market; they’re operating in a market that’s rigged to line their pockets and limit competition. The entire pharmaceutical industry in reality runs on government-granted monopolies, mostly in the form of long-term patent protections...
- The Top 5 Biosimilars Articles for the Week of December 10 (centerforbiosimilars.com)
Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
- December 14 Pharmacy Week in Review: Walmart Announces New Telehealth Service for Veterans, Study Weighs Risks and Benefits of Statins (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- FDA keeps spotlight on GMP data integrity (biopharmadive.com)
The Food and Drug Administration...issued a reminder to drug manufacturers that data integrity remains high on the regulator's agenda of Good Manufacturing Practice-related concerns, publishing new guidance aimed at helping drugmakers meet its standards...The document, which updates a 2016 version, lays out a series of questions and answers for drugmakers explaining how companies can ensure manufacturing data sets are complete, consistent and accurate. While a technical concern, the FDA makes clear that data errors carry real risk to patient health...Guidance isn't the only lever the FDA can pull to help companies comply. In recent years, the agency has flagged data integrity issues in numerous warning letters following inspections and pre-approval assessments.
- Four Democrats Introduce Senate Bill to Allow HHS to Block “Excessive” Drug Price Increases (centerforbiosimilars.com)S.3754 - A bill to prohibit price gouging in the sale of drugs. (congress.gov)
...Senators Richard Blumenthal, D-Connecticut, Kamala Harris, D-California, Amy Klobuchar, D-Minnesota, and Jeff Merkley, D-Oregon, introduced a bill on the Senate floor, S. 3754, that would allow HHS to block drug price increases that it deems as “excessive.”...The bill, dubbed “A bill to prohibit price gouging in the sale of drugs,” is just the latest in a series of actions that Congressmen and the government alike have taken to address high drug prices.
- China’s Zhejiang Huahai lambasted in FDA warning letter for putting profits ahead of safety (fiercepharma.com)
The Chinese API maker at the heart of a global scare and recall of blood pressure medicines has been savaged in an FDA warning letter for failing to uncover a suspected carcinogen in its APIs when a customer complained several years ago...The FDA said that when Zhejiang Huahai Pharmaceutical altered its manufacturing process in 2011 to include a solvent suspected of producing the impurity, it didn’t even consider that the changes might lead to the formation of mutagenic impurities in its valsartan APIs...“You failed to adequately assess the potential formation of mutagenic impurities when you implemented the new process,” the highly redacted warning letter says...Regulators in the U.S. and Europe continue to test products to try to ferret out all of the affected drugs. The FDA says there is very little risk of the impurities causing problems, and no adverse reactions have been seen...










