- As U.S. calls for stateside manufacturing, antibiotic maker Paratek gambles on ‘onshoring’ effort (fiercepharma.com)
...the U.S. government has shelled out big money for a stable and reliable supply of key drugs made on U.S. soil. For drugmakers accustomed to offshore manufacturing in cheaper countries, does it make any sense to onshore production to meet U.S. demand?...One company has a compelling argument, and it's taking big risks—and government funding—to test its hypothesis...Paratek Pharmaceuticals, maker of antibiotic Nuzyra, is kick-starting a three-year plan to build a government-funded, second supply chain in the U.S. in an effort to flesh out the nation's strategic supply of pandemic response drugs...The U.S. government, through its Biomedical Advanced Research and Development Authority, has dumped more than $300 million combined into helping Paratek build the U.S. supply line, which will stand apart from its current manufacturing network in Europe...READ MORE
- Amid a pandemic, Atlas becomes latest venture firm to raise cash for drug startups (biopharmadive.com)
The coronavirus pandemic hasn't deterred investors of Atlas Venture, a biotechnology-focused venture capital firm. On Friday, Atlas announced its latest fund, which opened at the end of March, had closed with a higher-than-expected yield of $400 million...Atlas initially wanted to bring in $350 million from the fund...But when the firm went out to fundraise, it was met with more than $1 billion in demand, which then pushed the fund toward a cap of $400 million...the fresh money will be put into about 15 companies, and that his firm remains interested in areas such as targeted cancer drugs, gene therapy and the central nervous system...The pandemic's impact on biotech stocks was fleeting compared to the larger market. Venture-backed drug companies have also continued to go public, which has kept firms and their investors optimistic about their ability to earn returns...While there are enormous parts of the broader economy...that have been really adversely affected by the COVID-related lockdowns, biotech is doing very well...The fund flows are very strong by any measure...READ MORE
- Pharma’s reputation is holding strong during COVID-19—and Harris Poll has some reasons (fiercepharma.com)
Pharma’s reputation is holding strong these days, the latest Harris Poll survey shows. That’s good news again for the industry—but why the change?...The Harris Poll asked Americans that question. And, perhaps unsurprisingly, the COVID-19 crisis is the reason...Seventy percent told the market researcher that the industry’s overall response to the pandemic is the main reason for their more positive feelings. Efforts to develop a vaccine (58%), develop or find treatments (56%), create diagnostic tests (56%) and protect medical professionals by providing masks and protective gear (46%) also rated as key reasons perceptions have changed...READ MORE
- FDA pushes metformin recalls for 5 drugmakers after carcinogen contamination (fiercepharma.com)
After the FDA identified a likely carcinogen in samples of the broadly used diabetes med metformin, recalls appeared likely. Now it's official...The FDA said Thursday it had asked five metformin manufacturers to pull their extended-release metformin products, after pushing recalls of heartburn med Zantac and "sartan" blood pressure drugs for the same reason. A likely human carcinogen, N-Nitrosodimethylamine, was discovered in samples of all three...READ MORE
- Europe wants to make its own drugs, but it needs American blood plasma (reuters.com)
Europe wants to be master of its own destiny in producing essential drugs and finding COVID-19 treatments, but it’s got a problem. It relies on the United States for a critical ingredient: blood plasma...As global mistrust deepens, European Union officials are casting around for ways to reduce the bloc’s dependence on American plasma...now widely applied in COVID-19 experimental therapies...The coronavirus crisis should push authorities to overhaul Europe’s blood donation system...The United States’ steadier plasma supplies are partly due to its system of paying people to donate blood used to develop medicines. In most European countries, donations are unpaid because of safety and ethical reasons...The PPTA (Plasma Protein Therapeutics Association ) drugmakers body sees a strategy based on unpaid blood donations as counterproductive. It pointed to Germany, the largest collector of plasma in Europe, as one of the few countries that compensate blood donors...READ MORE
- U.S. seeks to ‘onshore’ drug production in response to COVID-19. Is pharma even interested? (fiercepharma.com)
With the COVID-19 pandemic shining a spotlight on the global pharmaceutical supply chain, U.S. legislators have put forward a raft of legislation that would seek to "onshore" drug manufacturing at the expense of major producers abroad...Guess who's wary of that proposal? Big Pharma...the White House is reportedly working on a "Buy American" executive order that would require government agencies to purchase American-made medical products, and that order could eventually include pharmaceuticals...the Pharmaceutical Research and Manufacturers of America...has pushed back against Congressional support for a supply chain shake-up...Manufacturing stateside would likely cost a princely sum compared with the cheaper wages and lower costs abroad, and would upset the balance of pharma's global supply chain..."While we support efforts to foster more manufacturing in the United States, moving all manufacturing here is impractical and likely not feasible," a PhRMA spokesperson said in an email. "Policymakers must take a long-term, more holistic look at global pharmaceutical manufacturing supply chains before jumping to rash proposals that may cause significant disruptions to the U.S. supply of medicines."...READ MORE
- A top adviser for Trump is calling for more drug manufacturing in Puerto Rico. (fiercepharma.com)
The COVID-19 pandemic has underscored key weaknesses in the biopharma industry’s complex global supply chain, and now a top adviser for the Trump administration is calling on Congress to push for more manufacturing in Puerto Rico...White House trade adviser Peter Navarro faulted a “broken system” that pushes manufacturing offshore. He called on Congress to use the next round of COVID-19 relief to incentivize manufacturing on the island territory...Previously, a tax provision allowed U.S. companies to avoid paying federal taxes on profits from operations in Puerto Rico, but Congress phased that out over time...Plus, utility costs are significantly higher there than in the U.S., which has also led to a reduction in manufacturing. Pharma companies themselves have shuttered a number of drug plants in Puerto Rico in recent years...READ MORE
- The latest: What they are saying: Intellectual property protections critical as we work to defeat COVID-19 (catalyst.phrma.org)
The U.S. biopharmaceutical industry depends on reliable intellectual property protections to promote the development of new treatments and cures for patients. Strong IP protections are especially important as innovators work around the clock making substantial investments at risk to develop solutions to help prevent infection and treat those with COVID-19...many of the existing medicines and investigational medicines in clinical trials for COVID-19 exist today because of IP and other incentives that drove their initial research...Strong and reliable IP protections support America’s robust innovation ecosystem by promoting innovation and affordability for patients who rely on new treatments and cures...READ MORE
- U.S. awards new $628 million contract to boost output of potential COVID-19 vaccine (reuters.com)
The U.S. government...entered into a $628 million contract with drugmaker Emergent BioSolutions to boost manufacturing capacity for a potential COVID-19 vaccine...As drugmakers capacity here in America for candidates that make it to the final stages of Operation Warp Speed will help get a vaccine to American patients without a day wasted,” Department of Health and Human Services Secretary Alex Azar said in a statement...The HHS task order with Emergent falls under an existing contract with the Biomedical Advanced Research and Development Authority...Under the contract, Emergent will commit its manufacturing facilities, valued at $542.7 million, to produce COVID-19 vaccine candidates through 2021...READ MORE
- EMA urged to release full clinical trial data upon authorizing Covid-19 treatments (statnews.com)
Amid worldwide clamor for Covid-19 medicines and vaccines, the European Medicines Agency is being urged by several international clinical evidence experts...to publish all trial data on the same day any product is authorized for use against the novel coronavirus...In a letter to the European regulator, four country directors from the independent watchdog Cochrane and leaders from Germany’s Institute for Quality and Efficiency in Health Care argued that it is critical to promptly release clinical study reports to support further research and proper medical care. The reports are go-to documents that contain myriad details about the methods and results of a clinical trial...READ MORE