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More Than 60 Groups Ask Senate Leadership To Pass Legislation To Lower Drug Prices

In a letter to Senate leadership, several organizations asked for the passing of legislation that would reform the patent system and improve competition in the prescription drug space. By MARISSA PLESCIA More than 60 organizations sent a letter Wednesday to Senate Majority Leader Chuck Schumer (D-New York) and Senate Minority Leader Mitch McConnell (R-Kentucky). The letter calls for the passing of legislation that the organizations say would lower drug prices through patent reform and increased competition. The organizations include Patients for Affordable Drugs Now, a nonprofit fighting to lower prescription drug prices, and AARP, a nonprofit focused on Americans aged 50 and older. They call for the Senate leadership to advance the following bills: • S. 142, which would tamp down on pay-for-delay deals. This refers to when brand name drug makers pay potential generic and biosimilar competitors to prevent them from bringing their product to market. • S. 150, ...
- Source: drugdu
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- November 3, 2023
FDA Grants Fast Track Designation to Sellas Life Sciences’ SLS009 for Lymphoma

Don Tracy, Associate Editor SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas. Sellas Life Sciences announced that the FDA has granted Fast Track Designation to SLS009, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). The designation intends to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.1 “The FDA’s decision to grant SLS009 Fast Track designation signifies an important milestone towards developing a safe and effective treatment for PTCL, a group of aggressive and rare non-Hodgkin lymphomas, and underscores the urgent need for innovative therapies such as SLS009 that can significantly improve the outcome of PTCL patients,” said Angelos Stergiou, MD, ScD hc, president, CEO, Sellas, in a company press release. “SLS009 has demonstrated very promising clinical responses in PTCL patients in the recently completed ...
- Source: drugdu
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- November 3, 2023
Amgen scores FDA approval for Stelara biosimilar

Amgen’s interchangeable biosimilar version of Johnson & Johnson’s (J&J) Stelara, dubbed Wezlana (ustekinumab-auub), has received an US Food and Drug Administration (FDA) approval. The interchangeable biosimilar was approved for use in multiple inflammatory diseases, including for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderate to severe active ulcerative colitis. The agency approved Wezlana after a comprehensive review of scientific evidence, which showed that Wezlana was highly similar to ustekinumab and there were no clinically meaningful differences between the products in regard to safety, purity, and potency. Stelara was first approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis in September 2009. The FDA later approved the IL-12/IL-23 inhibitor’s use in moderate to severe Crohn’s disease in November 2016, and later for active psoriatic arthritis and ulcerative colitis. ...
- Source: drugdu
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- November 3, 2023
Novavax’s XBB.1.5-adapted COVID-19 vaccine receives EC approval

Novavax has announced that its updated COVID-19 vaccine, Nuvaxovid XBB.1.5, has been approved by the European Commission (EC) for active immunisation in individuals aged 12 and older. The decision follows a positive opinion for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Developed to target the Omicron XBB sublineage, the updated vaccine prepares the body’s defences against COVID-19 and contains a version of the spike protein of the Omicron XBB.1.5 subvariant, as well as Matrix-M adjuvant to strengthen immune response. The approval was based on non-clinical data which showed that the vaccine induced functional immune responses against the COVID-19 variants XBB.1.5, XBB.1.16 and XBB.2.3. Additionally, the updated vaccine induced neutralising antibody responses to newly emerging subvariants of the SARS-CoV-2 virus, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, as well as strong CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. Based on previous recommendations by ...
- Source: drugdu
- 209
- November 3, 2023
BioMarin’s longtime CEO Jean-Jacques Bienaimé hands the reins to Genentech’s Alexander Hardy

After 18 years at the helm, BioMarin’s CEO Jean-Jacques Bienaimé is hanging up the gloves. But he won’t be leaving the company without capable hands. Genentech CEO Alexander Hardy is leaving his current post—effective immediately—and will replace Bienaimé upon the BioMarin chief’s retirement on December 1. The transition comes after a “multi-year succession planning process” and a comprehensive search by BioMarin’s board, the company’s lead independent director Richard A. Meir said in a Wednesday statement. The Genentech CEO fit the bill as a candidate with “experience driving commercial growth and operational excellence,” Meier, who will now become chair of BioMarin’s board of directors, added. When Bienaimé took over BioMarin in 2005, the company was collecting some $26 million annually from its one marketed product, enzyme replacement therapy Naglazyme. Now, thanks to dwarfism med Voxzogo and hemophilia A gene therapy Roctavian, BioMarin recently turned a corner into profitability after many years ...
- Source: drugdu
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- November 3, 2023
Merck’s Keytruda nabs FDA nod in biliary tract cancer, catching up with AstraZeneca’s Imfinzi

After AstraZeneca’s Imfinzi last year claimed new territory in the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. The approval in locally advanced unresectable or metastatic biliary tract cancer, combined with the chemotherapies gemcitabine and cisplatin, marks Keytruda’s sixth U.S. nod in gastrointestinal cancer, Merck said. The FDA based the approval on data from the company’s Phase 3 KEYNOTE-966 trial, which showed that the Keytruda-chemo combo extended patients’ survival time compared with chemotherapy alone. In the study, patients in the treatment arm lived a median 12.7 months, compared to 10.9 months for those on solo chemo. The Keytruda-chemo combo reduced the risk of death by 17% over solo chemotherapy, researchers found. In addition, Keytruda-treated patients experienced a longer median duration of response at 9.7 months, compared with 6.9 months for solo chemotherapy. Merck is “proud” to offer the new treatment ...
- Source: drugdu
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- November 3, 2023
FDA posts updated safety data on Bayer’s Essure, notes progress on improving study

Dive Brief A postmarket surveillance study has linked Bayer’s Essure birth-control implant to a numerically higher rate of some safety outcomes than laparoscopic tubal sterilization (LTS). The latest interim analysis of the study, which the Food and Drug Administration asked Bayer to run, shows trends seen in previous years persisted. Rates of gynecologic surgical procedures and endometrial ablation were numerically higher in the Essure group. Bayer has acted on the FDA’s request for actions to improve follow-up rates in the study, leading the administration to remove the “inadequate” progress tag it applied to the trial last year. Dive Insight The origins of the postmarket surveillance study date back to 2016, when the FDA asked Bayer to collect data on the device. Bayer stopped selling the device in the U.S. two years later, framing the action as a business decision rather than a reflection of the safety of a product that ...
- Source: drugdu
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- November 2, 2023
AI may help identify potential gonorrhea vaccine proteins

Gonorrhea, a sexually transmitted bacterial infection that affects more than 80 million people worldwide every year, has become resistant to almost all known antibiotics. That makes it notoriously difficult to treat, but left untreated, an infection could lead to serious or even fatal complications. It also increases a person’s risk of contracting HIV. A new study suggests artificial intelligence (AI) may help identify a vaccine’s key ingredients. This week in mBio, an international collaboration between academic and commercial researchers reported the identification of 2 promising antigens as candidates for a gonorrhea vaccine. The researchers used an AI model called Efficacy Discriminative Educated Network, or EDEN, to identify the protective proteins. They also used EDEN to generate scores that accurately predicted how well antigen combinations would reduce pathogenic bacterial populations of Neisseria gonorrhoeae, the microbe that causes gonorrhea. “To the best of our knowledge, this correlation has not been shown before,” ...
- Source: drugdu
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- November 2, 2023
First U.S. procedure performed with ZimVie 4.5mm Mobi-C device

BY SEAN WHOOLEY The Mobi-C cervical disc. ZimVie (Nasdaq: ZIMV)+ announced today that the first U.S. patient received its new 4.5mm Mobi-C cervical disc. Mobi-C became the first cervical disc approved for one and two levels by the FDA in 2013. Ten years later, in August of this year, ZimVie picked up FDA approval for a smaller height for the device. The updated 4.5mm Mobi-C comes in seven footprints to match patient anatomy. Dr. Gregory D. Lopez of Midwest Orthopaedics at Rush in Chicago implanted the first of these devices in the U.S. on Oct. 30. “The 59-year-old patient presented with a significantly collapsed C5-6 disc, and the new lower profile Mobi-C implant allowed me to avoid over-distracting the facet joints,” Lopez said in a news release. “The 4.5mm height Mobi-C makes it possible for me to offer pain relief and motion preservation to more of my patients with cervical ...
- Source: drugdu
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- November 2, 2023
Eli Lilly Strikes $250M Deal to Add Gene-Editing Medicines for Cardio Conditions

Eli Lilly is acquiring Beam Therapeutics’ opt-in rights to three Verve Therapeutics gene-editing therapies for cardiovascular conditions. The deal comes four months after the pharmaceutical giant began a partnership on a preclinical Verve gene-editing therapy for a different target. By FRANK VINLUAN Eli Lilly signaled its growing interest in genetic medicines for cardiovascular conditions when it partnered with Verve Therapeutics earlier this year, committing to share in development of a preclinical gene-editing therapy addressing a key heart target. The pharmaceutical giant is now adding more cardiovascular disease drug prospects, pledging $250 million to secure the right to opt into development and commercialization of three additional Verve gene-editing therapies for other key targets. This time, however, the cash isn’t going to Verve. Lilly is paying Beam Therapeutics, whose base-editing technology is used in Verve’s experimental genetic medicines. Their original alliance, started in 2019, gave Beam the option to share in the ...
- Source: drugdu
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- November 2, 2023

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