Category:

The new coronavirus moved around the world with lightning speed. Since December, when it was first identified in Wuhan, China, nearly every country has reported cases of infection. More than 4.9 million cases have been confirmed...and over 327,000 people have died...Dozens of drugmakers have started work on vaccines to protect against the virus or medicines to treat COVID-19...Hundreds of studies are underway in search of an effective treatment, testing mostly repurposed HIV or influenza drugs...For the biopharma industry, the virus has disrupted business on a broad scale. Many companies source chemicals or pharmaceutical ingredients from factories across the globe, creating supply chain challenges...The epidemic's impact on clinical trials was significant, causing numerous delays to enrollment or postponements to studies of treatments for other diseases...BioPharma Dive compiled a roundup of our coronavirus coverage so far. There are many unanswered questions, and the drug industry's response is only in its opening stages...READ MORE

Last week, the Centers for Medicare and Medicaid Services released its final Notice of Benefit and Payment Parameters for the 2021 benefit year...This final rule permits insurers to exclude the value of a pharmaceutical manufacturer’s copay support program from a patient’s annual deductible and out-of-pocket maximum obligations...Translation: CMS has confirmed that insurers have the option to use copay accumulator adjustment for their pharmacy benefit programs...Patients on specialty drugs lose big from accumulators, while plans profit from the lower spending that results. Consequently, copay maximizers have emerged as a more patient-friendly alternative to accumulators...Plan sponsors are publicly denouncing copay support programs—while they’re privately embracing them. CMS’s final rule ignores the troubling reality behind maximizers and accumulators: They encourage plans to use pharmacy benefit deductibles as a scheme that allows payers—not patients—to reap the greatest benefits from a manufacturer’s patient support program...READ MORE

Gilead Sciences’ initial donation of remdesivir will be exhausted by early summer. The biotech will start charging for the drug in COVID-19 after that, and it might not be just a year or two of revenue flow...The company will pivot to a commercial plan after the donated supply of 1.5 million doses runs out around June or early July...The Institute for Clinical and Economic Review recently found remdesivir would be cost-effective at $28,670...But the U.S. drug cost watchdog argued that $50,000/QALY should be applied to remdesivir during a public health emergency. After that calculation, ICER pegged a reasonable price at $4,460...READ MORE

U.S. President Donald Trump’s administration awarded a contract worth up to $812 million for a new U.S. company to manufacture drugs and drug ingredients to fight COVID-19 on American soil, aiming to end dependence on other countries...The administration has been looking to build up the ability to produce drugs and their raw materials in the United States after the global pandemic exposed the industry’s dependence on China and India for its supply chain...The U.S Department of Health and Human Services said it had awarded a four-year, $354 million contract to privately-held Phlow Corp to make COVID-19 drugs, other essential drugs and their ingredients. The contract - which is for generic drugs, not more complicated products like vaccines - can be extended to a total of $812 million over 10 years...READ MORE

The COVID-19 pandemic has forced companies and organizations worldwide to change courses, and the U.K.’s Vaccines Manufacturing and Innovation Centre is no different. With a new £131 million contribution from the U.K. government, the center aims to both speed up and expand upon its prior ambitions...“This is a transformational moment for our organization to be part of a national and global response, and we’re very proud to be part of that,” Duchars said. Even beyond COVID-19, VMIC also aims to be a partner for vaccine developers worldwide that could tap its manufacturing and development expertise for various diseases...READ MORE

Tobacco and e-cigarette companies have been accused of using the COVID-19 crisis to advertise e-cigarettes on social media and “undermine minimum age purchase restrictions” that protect minors...The not-for-profit activist group Campaign for Tobacco-Free Kids analysed the marketing tactics of big tobacco, e-cigarette and vaping companies in 28 countries, including the UK...It found that on social media, the two largest tobacco companies – Philip Morris International and British American Tobacco – had appropriated ‘Stay at home’ hashtags used by governments and health authorities to market heated cigarette products, such as Glo and iQOS, and e-cigarettes, including Vype...READ MORE

The chief scientist brought on to lead the Trump administration’s vaccine efforts has spent the last several days trying to disentangle pieces of his stock portfolio and his intricate ties to big pharmaceutical interests, as critics point to the potential for significant conflicts of interest...Moncef Slaoui, is a venture capitalist and a former longtime executive at GlaxoSmithKline. Most recently, he sat on the board of Moderna...He resigned when President Trump named him last Thursday to the new post as chief adviser for Operation Warp Speed, the federal drive for coronavirus vaccines and treatments...In agreeing to accept the position, Dr. Slaoui did not come on board as a government employee. Instead, he is on a contract, receiving $1 for his service. That leaves him exempt from federal disclosure rules that would require him to list his outside positions, stock holdings and other potential conflicts. And the contract position is not subject to the same conflict-of-interest laws and regulations that executive branch employees must follow...READ MORE

Digital health technology is transforming every aspect of pharmacy practice, whether it deploys robotics to fill prescriptions, uses analytics to track medication data, or offers access to digital therapy. Pharmacists in both the hospital and retail settings are using recently developed technology to prevent adverse drug effects, monitor the use of antibiotics, modify unhealthy behavior, and promote medication adherence...Not only can technology make a pharmacist’s day more efficient by automating repetitive tasks, but new digital health products are providing more insight into data and the opportunity for real-time patient interaction...READ MORE

Monitoring Medication
Digiceuticals and Behavior Modification
Preventing Adverse Effects
Antibiotic Stewardship in Real Time

The COVID-19 pandemic is reshaping the global supply chain, and the Trump administration has a message for established generics drugmakers: Bring your manufacturing on shore, or we will find new companies that do...two recent contracts the U.S. government signed to bring drug manufacturing to American soil. But will companies follow?...The HHS’ Biomedical Advanced Research and Development Authority just inked a $354 million four-year deal with a company called Phlow to make generic medicine and active pharmaceutical ingredients in Virginia. The Department of Defense awarded a $138 million grant to ApiJect to expand U.S. production capability for prefilled syringes, following a $450 million deal the company won from the HHS...Both deals fall in the injectables category and involve significant investments to upgrade facilities and purchase future products. They both tap relatively new companies, which appear to be using innovative manufacturing technologies...Where does that leave traditional generic players such as Teva, Novartis’ Sandoz and Mylan? They may choose to join in...READ MORE

WuXi Biologics has angled for years to expand its manufacturing base out of China and into promising hubs in Europe and the U.S. Now, nearly two years after its plans were first announced, WuXi has secured a deal to build a new facility in Massachusetts in the biotech hotbed of the greater Boston area...WuXi clinched a deal with the Worcester Business Development Corporation to build its first U.S. biologics facility at a 46-acre master-planned manufacturing hub dubbed The Reactory..."We stand ready and able to help our global partners advance their innovative and life-saving ideas," Chen said. "Together, I am confident that we have much to contribute to the biologics industry and patients worldwide."...READ MORE