• Gilead’s latest HIV drug is a biannual injection that could improve disease prevention by addressing stigma and adherence issues.
• Moderna’s next-gen COVID-19 vaccine has succeeded in a Phase 3 study, offering increased effectiveness for adults.
• The New York Times recently investigated pharmacy benefit managers (PBMs), highlighting both the complexity of our healthcare system and PBM practices that force patients to either choose higher drug costs or go without lifesaving treatments.

Recent News

• Mail-Order Drugs Were Supposed to Keep Costs Down. It’s Doing the Opposite
  The Wall Street Journal – June 25, 2024
  A key tool that businesses have counted on to keep a lid on employees’ drug spending—filling workers’ prescriptions by mail—is now driving up their costs. Unity Care NW, a nonprofit health clinic in Washington state, forecasts the cost of medical and drug benefits for its 365 employees and their family members will increase this year by 25% to more than $3 million. A big reason: Drugs delivered by mail are costing multiples more than those picked up at a store counter.
• The Opaque Industry Secretly Inflating Prices for Prescription Drugs
  The New York Times – June 21, 2024
  Americans are paying too much for prescription drugs. It is a common, longstanding complaint. And the culprits seem obvious: Drug companies. Insurers. A dysfunctional federal government. But there is another collection of powerful forces that often escape attention, because they operate in the bowels of the health care system and cloak themselves in such opacity and complexity that many people don’t even realize they exist. They are called pharmacy benefit managers. And they are driving up drug costs for millions of people, employers and the government.
• AbbVie’s rising star Skyrizi nabs key ulcerative colitis FDA approval
  Fierce Pharma – June 20, 2024
  AbbVie’s fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales. Now, the IL-23 inhibitor is poised to take on an even larger share of Humira’s fading market dominance with a key expansion into ulcerative colitis. On Tuesday, the FDA granted Skyrizi approval to treat adult patents with moderately to severely active ulcerative colitis (UC). The approval adds some 1 million U.S. patients to the drug’s reach and makes Skyrizi the first IL-23 inhibitor cleared to treat both UC and Crohn’s, the two forms of inflammatory bowel disease (IBD). Following a 12-week induction period, patients can dose themselves at home with an on-body injector device “designed with patients in mind,” according to AbbVie’s press release.
• J&J’s subcutaneous version of Tremfya excels in Crohn’s disease study
  Fierce Pharma – June 20, 2024
  Johnson & Johnson touted the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn’s disease. A month later, a subcutaneous (SC) version of Tremfya has excelled as an induction therapy in a phase 3 Crohn’s disease study. In the GRAVITI trial, Tremfya met both co-primary endpoints, delivering a statically significant improvement versus placebo at week 12 for both remission and endoscopic response. With the results of the three studies, Tremfya has shown its potential to become to the first IL-23 inhibitor to offer two induction options for Crohn’s disease, J&J said in a press release.
• Twice-yearly shots of Gilead HIV drug effective in large prevention study
  Biopharma Dive – June 20, 2024
  Gilead has made oncology a focus of its dealmaking in recent years, investing tens of billions of dollars in acquisitions of cancer drugs and their developers. But the bulk of Gilead’s business remains in HIV, a field it has long led with a portfolio of pills approved to prevent or treat infections. Lenacapavir is its latest entrant and, as an injection given twice per year, could represent a more convenient way for people to protect against the disease. “While we know traditional HIV prevention options are highly effective when taken as prescribed, twice-yearly lenacapavir for [pre-exposure prophylaxis, or PrEP] could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule,” said Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, in a statement provided by Gilead.
• World Sickle Cell Day 2024: A day to celebrate, a day to reflect
  Bio News – June 19, 2024
  June 19 is a day of dual significance: World Sickle Cell Day and Juneteenth. It’s a day of celebration, acknowledging the remarkable progress in treating sickle cell disease (SCD). However, it’s also a day of reflection on the work still needed to address healthcare disparities. SCD is a genetic disorder that causes red blood cells to become crescent-shaped, leading to severe health complications such as pain, fatigue, organ damage, and an increased risk of infections. On World Sickle Cell Day 2023, we asked whether patients might soon have access to new treatments. On World Sickle Cell Day 2024, groundbreaking gene therapies are available.
• UC San Diego receives FDA clinical trial approval for brain recording device
  Fox 5 San Diego – June 18, 2024
  University of California, San Diego engineers have developed an electronic grid that records brain activity during surgery. The device, known as platinum nanorod grid (PtNRGrid), has received Federal Drug Administration approval for a clinical trial, the university said in a news release on Monday. PtNRGrid features a record-breaking 1,024 embedded electrocorticography (ECoG) sensors, compared to typical ECoG grids that have between 16 and 64 sensors used in surgeries, according to the university.
• Boosting hepatitis C treatment would save money, CBO says
  Axios – June 18, 2024
  Doubling the number of Medicaid enrollees receiving hepatitis C treatments would avoid about $7 billion in health care costs over a decade, according to a new Congressional Budget Office report on the burden the liver disease places on medical care and safety net programs. About 70,000 people are newly infected with hepatitis C each year in the U.S., and complications in untreated patients can be 10 times as costly as administering antivirals in earlier stages of the disease.
• Intra-Cellular’s Caplyta scores again in major depressive disorder as blockbuster expansion comes within reach
  Fierce Pharma – June 18, 2024
  Intra-Cellular Therapies’ surging antipsychotic Caplyta has scored again with remarkable trial results, fueling its bid for a third and potentially most lucrative indication—major depressive disorder (MDD). In U.S. patients with MDD, a 42 mg daily dose of Caplyta (lumateperone) as an adjunctive therapy provided a 4.5-point reduction on the Montgomery-Asberg Depression Rating Scale (MADRS) at week 6 compared to placebo.
• AstraZeneca Imfinzi plus chemotherapy gets US nod for certain type of endometrial cancer
  Reuters – June 17, 2024
  AstraZeneca opens new tab said its blockbuster cancer drug Imfinzi combined with chemotherapy has been approved by the U.S. as treatment for adult patients with primary, advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). The approval from the U.S. Food and Drug Administration came after a late stage trial showed that Imfinzi along with chemotherapy drugs carboplatin and paclitaxel, then followed by Imfinzi by itself, reduced the risk of disease progression or death by 58% in specific endometrial cancer patients, compared to chemotherapy alone, said the Anglo-Swedish drugmaker.
• J&J’s DePuy Synthes orthopedics robot cleared for partial knee replacements
  Fierce Biotech – June 17, 2024
  Johnson & Johnson MedTech’s orthopedics division, DePuy Synthes, has claimed an FDA clearance for its Velys surgical robot that expands its use into partial knee replacements. While total knee replacements make up the much larger share of procedures to treat osteoarthritis—where Velys obtained a green light in 2021—partial implant surgeries can offer patients the chance to preserve more natural bone and have potentially faster recovery times.
• Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults
  Fierce Pharma – June 17, 2024
  The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection. While the nod applies to people at least 18 years of age, Capvaxive is specifically adapted for patients age 50 and older as the 21 serotypes it covers account for 84% of the pneumococcal disease of people in the age group, according to epidemiologic data from the CDC.
• Ultragenyx wins surrogate endpoint debate, securing green light to seek FDA approval of gene therapy
  Fierce Biotech – June 13, 2024
  Ultragenyx Pharmaceutical’s work to get the FDA to recognize a biomarker as a surrogate endpoint looks to have paid off. With the agency agreeing the biomarker is a reasonable surrogate endpoint, Ultragenyx is preparing to file for approval of its Sanfilippo syndrome gene therapy around the end of the year.
• San Diego’s life sciences industry has long history of historic breakthroughs
  San Diego Union Tribune – June 11, 2024
  Imagine a city where cutting-edge science is not just a pursuit of knowledge but a beacon of hope, lighting the way for those seeking a better life. Over 19,000 life science professionals from around the world flooded our city for the Biotechnology Innovation Organization’s (BIO) annual convention.
• FDA OKs Iqirvo, First-in-Class PPAR Treatment for Primary Biliary Cholangitis
  Medscape – June 11, 2024
  The US Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor; Ipsen) for treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who do not respond adequately to UDCA or as monotherapy in patients unable to tolerate UDCA. PBC is a rare, chronic cholestatic liver disease that destroys interlobular bile ducts and leads to cholestasis and liver fibrosis. Left untreated, the disease can worsen over time, leading to cirrhosis and liver transplant and, in some cases, premature death. PBC also harms quality of life, with patients often experiencing severe fatigue and pruritus. Iqirvo, an oral dual peroxisome proliferator–activated receptor (PPAR) alpha and delta agonist, is the first new drug approved in nearly a decade for treatment of PBC.
• Covid-flu combination vaccine shows positive results in late-stage trial, Moderna says
  CNN – June 10, 2024
  There could be a combined Covid-19 and flu shot in our future, although it won’t be ready for this year’s flu season. On Monday, vaccine maker Moderna announced positive late-stage trial results for its Covid-flu combination vaccine it calls mRNA-1083. Calling the outcome of the late-stage trial “breakthrough results,” Moderna’s Chief Medical Affairs Officer Francesca Ceddia told CNN that people in the trial who got mRNA-1083 showed an improved immune response compared with those who got the standalone flu and Covid vaccines that are available now.
• Lilly Alzheimer’s drug gets unanimous backing of FDA pane
  BioPharmaDive – June 10, 2024
  An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration. The panel unanimously voted that the medicine, developed by Eli Lilly and known as donanemab, appears to be an effective treatment for certain Alzheimer’s patients. The experts also concluded, by an 11-0 vote, that the drug’s benefits outweigh its risks, despite some safety concerns.
• FDA approves first RSV vaccine for at-risk adults in their 50s
  CBS News – June 7, 2024
  The Food and Drug Administration has approved giving GSK’s vaccine for respiratory syncytial virus down to age 50 years old, to those who are at higher risk of severe RSV, the company said, making it the first shot greenlit for use in this age group to guard against RSV. Global vaccine and drugmaker GSK asked the FDA in February to expand approval beyond adults 60 and older, citing data showing the immune response in adults vaccinated from this younger age group looked similar. Further trials are planned looking at adults between 18 and 49 years old, GSK said, with results expected in the second half of this year.
• Novavax will be able to supply COVID-19 vaccines this fall
  Stat News – June 6, 2024
  The Food and Drug Administration’s vaccine advisory panel voted unanimously to recommend that this fall’s COVID-19 shots should be updated to target viruses in Omicron’s JN.1 lineage. That recommendation, if accepted by the FDA, is broad enough to ensure that Novavax, which has struggled to gain a substantial share of the COVID-19 vaccine market, will be able to supply product to the U.S. this fall.