Tirzepatide and Weight Loss – A New Era for Obesity Medicine
Eli Lilly’s tirzepatide was recently approved for weight loss by the US FDA. A newly published study in the New England Journal of Medicine shows that the drug has similar effects to gastric bypass surgery. The data further supports the use of the drug to treat obesity, which is associated with conditions like cardiovascular disease, diabetes, and some cancers. Patients with a BMI 30 or greater that took the drug and got counseling for healthy eating and exercise lost 20.9% of their body weight in 72 weeks, compared to 3% body weight loss in the placebo group. This has big implications for patients, providers, and payers.
Moderna Looking At $100 COVID-19 Vaccines
With the US federal government ending free COVID-19 vaccines by the end of 2022, Moderna has begun deliberating the cost it will charge for the shots on the commercial market. Arpa Garay, COO of Moderna, spoke with investors Tuesday, September 8th, informing them of the company’s move towards value-based pricing. The proposed $100 price tag would be triple that paid by the US government during the ongoing pandemic.
STATUS List 2022 Spotlight Series
STAT News is hosting its 2022 STATUS List Spotlight Series beginning September 20th. The series will highlight movers and shakers in the life science fields. Talks will cover the spotlighted professionals’ personal stories of their backgrounds, careers, and ideas for their fields moving forward. The first talk features Kirsten Bibbins-Domingo M.D., Ph.D., M.A.S..
Webinar: Fit for Local Context? Establishing or Improving Deliberative Processes for HTA
Pharma, biotech, and other stakeholders are increasingly being involved in deliberative processes for health technology assessment decisions, but navigating these interactions is not always clear. ISPOR and Health Technology Assessment International (HTAi) recently released a guidance for deliberative processes. This guidance and the thought processes behind it will be laid out in an upcoming webinar on September 30th.
COVID-19 Antibody Treatments Continue Well After FDA Deauthorization
Despite the best efforts of the US Food and Drug Administration (FDA), the use of Eli Lilly and Regeneron’s monoclonal COVID-19 antibody treatments is still prevalent. Nearly 160,000 doses of the therapeutics have been given since the two were deauthorized by the FDA this January. An estimate of the total healthcare cost is approximately $71 million.
Webinar: Overcoming Patient Recruitment Challenges in Rare Disease Trials
Nearly 450 million people live with rare diseases globally. This diverse population needs treatment options, but clinical trials are made [...]
Novo Nordisk Picks Up Forma Therapeutics for $1.1 Billion
Novo Nordisk has reached an agreement to acquire Forma Therapeutics for $1.1 billion. A key therapeutic Novo Nordisk will acquire with the purchase is etavopivat, Forma’s drug candidate for sickle cell disease (SCD). The drug is being developed to help treat the anemia and damage to red blood cells caused by the genetic disorder, which affects 17 million people globally.
Pfizer’s Oncology Chief Schmeltz Moves to Rare Disease Role
Pfizer is having another executive shakeup. Andy Schmeltz will leave his role as global president of oncology at Pfizer to take on a new role of managing the pharma juggernaut’s investment strategies. Suneet Varma will leave his position as the head of Pfizer’s rare disease division to fill in Schmeltz’s former role.
Horizon Plans Major Manufacturing Facility Expansion in Ireland
The CEO of Horizon Pharmaceuticals announced a major expansion of its manufacturing facilities in Ireland in a Q2 call. Tim Walber told analysts that the company will add 320,000 square feet (29730 square meters) onto its Waterford facility, which currently sits at 44,000 square feet (4,090 square meters). Horizon will hire 350 new employees for the plant, which was purchased last year.
Would AI substitute or (only) support market access managers, Dr. Andree Bates?
Dr Stefan Walzer, market access expert, and his guest Dr. Andree Bates, expert in artificial intelligence (AI), are discussing the future [...]
Generic Adderall Shortage Worsens Amid Growing Demand
Generic extended-release Adderall is now on back order from three more generic drug manufacturers. Novartis, Rhodes Pharmaceutical, and Amneal Pharmaceuticals have now joined the ranks of Teva, which experienced its shortage early this month. The shortage syncs up with a jump in demand caused by record highs in new Adderall prescriptions.
Endpoints Webinars: How the Current Investment Landscape is Stifling Rare Disease Development – September 15th
Despite the pressing need for appropriate treatments, the investment landscape is not amenable to therapeutic development. In an Endpoints webinar hosted on September 15th, speakers will discuss the current state of rare disease drug development funding and how the industry can foster innovation in spite of these difficulties.
Pfizer Joins VitaDAO Project to Promote Human Longevity
Pfizer has announced it will join VitaDAO, a decentralized program intended to promote programs that would extend human life if successful. The pharma titan will spend $500,000 to enter the project, which is touted as the industry’s first fully decentralized IP. The collective intends to use blockchain technology for early-stage funding decisions in the longevity field.
Gilead Asks US Supreme Court to Dismiss Bristol Myers Squibb’s Petition in CAR-T Case
Gilead Sciences has asked the US Supreme court to drop Bristol Myers Squibb’s petition for the court to take up its $1.2 billion CAR-T case that was overturned by an appeals court one year ago. The case is figuratively a proxy war between the two giants over CAR-T technology, with Gilead’s Kite Pharma taking on the Case against BMS’s Juno Therapeutics. Gilead is asking the court to dismiss the case because they claim BMS’s patent is too broad.
Pharma CI USA 2022 | September 21-22 | Newark, NJ
Competitive intelligence (CI) is essential for success in pharma and biotech. CI professionals from across the industry will meet at Pharma CI USA 2022 in Newark, NJ from September 21-22. Attendees will have the chance to network with other senior-level CI professionals and attend talks hosted by experts in the field.
US Federal Circuit Court Grants Win to AbbVie in Whistleblower Case
This Thursday, August 25th, Zachary Silbersher lost his whistleblower case with AbbVie in a US federal circuit court. Silbersher filed suit in 2018 over claims the company Allergan, now owned by AbbVie, and Adamas misrepresented data regarding their drugs for Alzheimer’s when applying for patents. The case was dismissed by the 3 judges, who unanimously decided that whistleblower cases cannot be based on publically available information. Silbersher is an experienced patent lawyer that did not work for any of the involved companies.
Webinar: When the Barrier to a Breakthrough Drug is You Can’t Make It – September 28th
Many new, promising drugs get stuck at the manufacturing stage of the market access pipeline due to complicated processes and scaling up operations. In a new STAT News webinar, speakers from Biomarin, BioNTech, and STAT will discuss how they met these challenges and how pharma and biotech companies can get past these common hurdles. The webinar takes place on September 28th.
Novartis Will Spin Off Sandoz into Standalone Company
Novartis will separate Sandoz, its generics division, into a standalone company. According to Novartis, the move will improve both company’s value to shareholders by letting them participate in decision-making for both companies individually. While Sandoz focuses on generics, Novartis will continue to lean into its central therapeutic foci.
ICER Review Casts Doubt on Value of Two ALS Drug Candidates
A new report by the Institute for Clinical and Economic Review (ICER) finds that 2 amytrophic lateral sclerosis (ALS) drug candidates from Amylyx and Mitsubishi Tanabe Pharma America have “low long-term value at their current suggested prices. Although the drugs both provide some benefits over the standard of care, the benefits do not justify the high price tag, the report notes.
New App from French Biotech Personalizes Drug Side Effects
Side effects are a significant contributor to hospitalization and treatment discontinuation. A new free app called Goodmed from Synapse Medicine lets users enter important details from their medical history and generates a detailed personalized list of potential side effects they may experience. Information provided by the app is contributed by official ANSM documents and the expert physicians and pharmacists at Synapse.
Cytel Webinar: US Drug Pricing Reform: Potential impact on Pharma HEOR Evidence Generation – September 8th
The new drug pricing legislation passed by the US government is set to change the game for the pharmaceutical industry. Medicare will negotiate the prices of certain drugs, so making a convincing case for a drug’s value is more important than ever. In a new Cytel webinar on September 8th, Cytel’s Anna Forsythe and Dr. Edmund Pezalla of Enlightenment Bioconsult will discuss the effects of the new legislation on drug pricing and how to use health economics and outcomes research (HEOR) in value assessment.
Regulatory Filing Shows Bidding War Between Major Retailers Over One Medical
Major retailers have increasingly eyed tech-enabled care providers for M&As in recent years, as typified by Amazon’s recent purchase of One Medical. A recent regulatory disclosure shows that another big retailer was vying for the company, CVS. The pharmacy giant had been in discussions with One Medical as early as October of last year.
US Inflation Reduction Act Drug Pricing Legislation May Impact Pharma’s Credit
A recent analysis by Moody’s Investment Service finds that drugmakers’ concerns about the US Democrats’ landmark drug pricing reforms may have some degree of validity. The legislation, which lets Medicare negotiate the price of a small set of drugs, would negatively affect the credit of the pharma industry. It would also cap inflation-attributed price hikes.
Biden Administration Looks to Stop Coverage of COVID-19 Vaccines and Treatments
As the US government increasingly relaxes COVID-19 guidances, the Biden administration is planning for the end of coverage for COVID vaccines and treatments. A planning session will be held by the Department of Health and Human Services on August 30th to discuss the matter with pharma representatives and officials from state health departments.
FDA Issues Warning to Emergent Biosolutions
Emergent Biosolutions has received a warning from the US Food and Drug Administration (FDA) regarding concerns about its Baltimore manufacturing plant, as disclosed in an SEC filing last week. The agency notes that there are serious issues in the facility’s aseptic processing and its cleaning and upkeep of equipment that prevents drug product contamination from particulates.
