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Gilead Sciences opens a new chapter, publishes the world’s ‘hardest book to read’ to reveal patients stuck in the margins

Depicting the plight of patients with chronic and potentially fatal diseases is always a challenge for pharma companies, but Gilead Sciences has quite literally found a novel way forward.Teaming up with British historian, presenter and writer Professor David Olusoga, OBE, Gilead is launching “From the Margins,” (PDF) in what is intended to be one of the most difficult books to read. That’s because the book has every word printed entirely in the margins of the pages in what Gilead and Prof. Olusoga see as a direct inversion of a normal book. The idea is simple: “To tell the profoundly moving personal stories of marginalized people living with HIV, Hepatitis C and cancer,” according to a statement sent to Fierce Pharma Marketing. Gilead markets drugs for all three diseases. The book is specific to Britain and being run to “to raise awareness of the issue of marginalization and health inequality in ...
- Source: drugdu
- 116
- September 16, 2023
Alnylam’s RNA interference drug wins favour of FDA AdCom

The US Food and Drug Administration (FDA) voted nine to three in favour of expanding the label of Alnylam Pharmaceuticals’ Onpattro (Patisiran) at a 13 September Advisory Committee (AdCom) meeting. A possible approval would allow the drug to be used to treat cardiomyopathy caused by a wild-type or hereditary transthyretin-mediated amyloidosis (ATTR/ ATTR-CM). At a Cardiovascular and Renal Drugs AdCom meeting, a panel reviewed results from the Phase III (NCT03997383) APOLLO-B trial. In the study, the drug showed favourable effects on functional capacity and quality of life. The drug also demonstrated a good safety profile through the 18 months of treatment with most adverse events being mild or moderate, as per May 2023 interim results. The AdCom discussed if the results from the APOLLO-B study were enough to prove a clinically meaningful benefit for the drug in the new indication. Dr Eric Peterson, a professor of internal medicine at the ...
- Source: drugdu
- 185
- September 16, 2023
NICE recommends use of Vydura for acute migraines on the NHS

Adults in England and Wales with acute migraines will now have access to a new treatment after the National Institute for Health and Care Excellence (Nice) recommended Pfizer’s Vydura for use on the NHS. In May, NICE recommended the drug – with the generic name rimegepant – for the prevention of migraines. At the time, NICE said up to 145,000 people would benefit from the treatment, though the drug was only permitted for use as a fourth-line treatment option. As per the most recent draft guidance, the drug has now been recommended for adults who do not respond to two previous migraine medicines, called triptans. Although this means Vydura is still not recommended for primary use, the move will help an additional 13,000 people access the treatment, NICE said. Patients who do not benefit from taking nonsteroidal anti-inflammatory drugs or paracetamol have also been endorsed to take the treatment in ...
- Source: drugdu
- 113
- September 16, 2023
Senators Introduce Bipartisan Bill To Impose Harsher Penalties On Those Who Assault Healthcare Staff

Recent research shows that about two-third of clinicians have felt physically unsafe at their job. This week, lawmakers introduced bipartisan legislation to address this concerning trend of violence waged against healthcare workers by giving them federal protections that mirror those for aircraft and airport workers. The bill, called the Safety from Violence for Healthcare Employees Act, would make it a federal crime to assault hospital workers. It was introduced by Sens. Marco Rubio (R-Florida) and Joe Manchin (D-West Virginia). The legislation can be thought of as the Senate’s rendition of the SAVE Act — the SAVE Act is a 2019 bipartisan bill that was reintroduced in Congress this year by Reps. Madeleine Dean (D-Pennsylvania) and Larry Bucshon (R-Indiana), but it has failed to advance. Even though nearly 40 states have passed laws to intensify penalties for violent acts committed against healthcare personnel, there is currently no federal law protecting hospital ...
- Source: drugdu
- 126
- September 16, 2023
Insulin pump-makers grapple with questions about GLP-1s

Insulin pump-makers face questions about whether a new category of weight loss drugs will affect their long-term growth prospects. Companies including Insulet and Tandem Diabetes Care saw their stock prices fall after a small study showed that GLP-1 agonists — which include the branded drugs Ozempic, Wegovy and Mounjaro — allowed people with Type 1 diabetes to reduce or stop insulin injections. Shares of Insulet have declined 22% in the last month to $173.90, and shares of Tandem have declined 20% to $23.14. However, physicians surveyed by analysts were skeptical the drugs would change the long-term outlook for diabetes, noting that the study only included 10 patients who started GLP-1s within three months of being diagnosed. William Blair analyst Margaret Kaczor cited interviews with three physicians, including Insulet Medical Director Trang Ly, who all said there was no evidence GLP-1s reverse damage to the insulin-producing beta cells in the pancreas. ...
- Source: drugdu
- 104
- September 16, 2023
BMS Culls Two Mid-Stage, Four Early-Stage Clinical Programs

By Connor Lynch Pictured: Bristol Myers Squibb in New Jersey/iStock, arlutz73 Bristol Myers Squibb has trimmed its development pipeline, announcing at an R&D Day on Thursday that the company would be cutting two mid-stage and four early-stage clinical programs for efficacy and safety reasons. Two Phase II clinical programs were on the BMS chopping block, including an investigational asset targeting heat shock protein 47 (HSP47), a small interfering RNA (siRNA) for nonalcoholic steatohepatitis (NASH), which was licensed from Nitto Denko for an upfront payment of $100 million in 2016. The compound inhibits expression of the heat shock protein, which is associated with excessive collagen buildup such as occurs in NASH, which is the most severe form of fatty liver disease. In 2019, BMS completed a Phase II trial investigating two different doses of the siRNA in 61 patients with scar tissue buildup post-hepatitis C infection. Neither dose performed better than ...
- Source: drugdu
- 210
- September 16, 2023
AbbVie Passes on License Option for Harpoon’s TriTAC Multiple Myeloma Program

By Tristan Manalac Pictured: AbbVie corporate office in California/iStock, vzphotos AbbVie will not exercise its exclusive licensing option for Harpoon Therapeutics’ HPN217 program, being developed for the treatment of multiple myeloma, the immuno-oncology biotech announced Wednesday. Harpoon will retain exclusive ownership over HPN217, for which it is running a Phase I clinical trial. The company will complete the study and plans to advance the candidate through its next phases of development. Despite AbbVie’s decision, Harpoon CEO Julie Eastland said in a statement that the biotech remains “confident in HPN217’s potential” to offer multiple myeloma patients “a differentiated treated option.” The company will share interim results from the candidate’s Phase I study at the upcoming International Myeloma Society (IMS) Annual Meeting, scheduled for Sept. 28, Eastland said. Developed using Harpoon’s proprietary TriTAC technology, HPN217 targets the B-cell maturation antigen, a protein highly and specifically expressed on myeloma cells. TriTAC, which stands ...
- Source: drugdu
- 111
- September 16, 2023
AbbVie shares positive results from head-to-head study of Skyrizi in Crohn’s disease

AbbVie has shared positive top-line results from a head-to-head study of its interleukin-23 inhibitor Skyrizi (risankizumab) in Crohn’s disease. The late-stage study, SEQUENCE, has been evaluating the drug against Johnson & Johnson’s Stelara (ustekinumab) in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Skyrizi was shown to match Stelara in terms of clinical remission at week 24, with remission rates of 59% in the Skyrizi group and 40% in the Stelara cohort. On the second primary endpoint of endoscopic remission at week 48, Skyrizi demonstrated superiority to Stelara, with remission rates of 32% and 16%, respectively. All secondary endpoints achieved statistical significance for superiority versus Stelara, AbbVie said, and safety results were consistent with the overall safety profile of Skyrizi. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. It is ...
- Source: drugdu
- 152
- September 15, 2023
HHS argues Merck ‘lacks standing’ to sue over Medicare price negotiations

Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). But the New Jersey drug giant “lacks standing” to challenge the law in court, the Biden administration argued in a new filing. Monday, the Department of Health and Human Services (HHS) argued that Merck can’t sue the agency because it isn’t the primary manufacturer for the diabetes med Januvia—one of 10 medications up for the first round of price negotiations in 2026. Simply put, HHS argues a Merck subsidiary is the company set to face the negotiation process, not Merck itself. Merck has argued it stands to suffer harm from the price negotiations because it developed and markets Januvia. But that assertion is “incorrect,” according to HHS, because a “non-party” to the lawsuit, Merck Sharp & Dohme, holds the FDA license to Januvia. “Accordingly, [the Centers for ...
- Source: drugdu
- 112
- September 15, 2023
FDA to start review of subcutaneous Entyvio for Crohn’s disease

The US Food and Drug Administration (FDA) has accepted Takeda’s biologics license application (BLA) for the company’s investigational subcutaneous administration of Entyvio (vedolizumab) for the treatment of Crohn’s disease. The BLA, which is for maintenance therapy of moderate to severe active forms of the disease after induction therapy with IV vedolizumab, will now be reviewed by the FDA alongside a separate BLA submitted by Takeda for the same formulation indicated for ulcerative colitis treatment. Dr Vijay Yajnik, vice president and head of US Medical for Gastroenterology at Takeda said in a statement: “With two applications for a subcutaneous option of Entyvio now under FDA review, we remain firm in our commitment to the inflammatory bowel disease community—adults with ulcerative colitis or Crohn’s disease—and the healthcare professionals actively managing their care.” Takeda submitted the most recent BLA with data from a Phase III clinical trial demonstrating that Entyvio led to a ...
- Source: drugdu
- 132
- September 15, 2023

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