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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
- 104
- 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
- 102
- 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
- 117
- 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
- 183
- 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
- 105
- 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
- 186
- November 2, 2023
Sarepta Fails Confirmatory Trial for DMD Therapy, Still Eyes Label Expansion

By Tristan Manalac Sarepta Therapeutics on Monday posted topline data from the Phase III EMBARK study, showing that its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec-rokl) fell short of its primary efficacy endpoint, unable to significantly improve functional mobility versus placebo. Nonetheless, based on what the company calls “robust evidence” of “clinically meaningful treatment benefit” across all EMBARK’s pre-specified key functional secondary endpoints, Sarepta will push through with filing for a label expansion for Elevidys. “We have shared the EMBARK topline results with FDA leadership and they have confirmed that, based on the totality of the evidence, they are open to such label expansion if supported by review of the data, and that they intend to proceed rapidly with consideration of the submission,” Sarepta CEO Doug Ingram said in a statement. In EMBARK, a randomized, two-part crossover and placebo-controlled study, Sarepta dosed 125 Duchenne muscular dystrophy (DMD) patients aged ...
- Source: drugdu
- 117
- November 2, 2023
Pfizer Continues COVID Cliff in Q3 with First Quarterly Loss Since 2019

By Tyler Patchen Pfizer reported third-quarter financial results Tuesday, pulling in $13.2 billion in revenues, a 42% drop compared to the prior-year period and the first quarterly loss since 2019. Third-quarter revenues for antiviral treatment Paxlovid dropped 97% operationally compared with the prior-year period, while COVID-19 vaccine Comirnaty revenues declined 70% in the quarter. However, Pfizer’s non-COVID products grew 10% operationally. Sales of its other vaccines, such as Prevnar 13 and 20 for pneumococcal conjugate vaccination, brought in over $1.8 billion in the third quarter while its RSV vaccine Abrysvo pulled in $375 million. “We are encouraged by the strong performance of Pfizer’s non-COVID products in the third quarter of 2023, including significant contributions from new launches and robust year-over-year growth for several key in-line brands,” CEO Albert Bourla said in a statement. Pfizer CFO David Denton noted in the release that new product launches will meet the company’s non-COVID ...
- Source: drugdu
- 116
- November 2, 2023
Merck KGaA and Hengrui Pharmaceuticals announce oncology partnership worth over €1.4bn

Merck KGaA has signed a licensing agreement worth over €1.4bn with Jiangsu Hengrui Pharmaceuticals for the rights to its next-generation PARP1 inhibitor HRS-1167 outside of China. The deal also includes an option for an exclusive licence for its Claudin-18.2 antibody drug conjugate (ADC), SHR-A1904. Compared to first-generation PARP inhibitors, HRS-1167 has higher selectivity and affinity for PARP1 and induces DNA trapping, Merck said, adding that the candidate is currently in phase 1 clinical development and “has the potential to be used as a monotherapy and as part of a combination therapy for treating a wider range of patients”. Danny Bar-Zohar, global head of research and development and chief medical officer for the Healthcare business of Merck KGaA, said: “This partnership with Hengrui fully aligns with both our external innovation ambition and our oncology research and development strategy by diversifying our robust internal pipeline in our focus areas of DNA damage ...
- Source: drugdu
- 114
- November 2, 2023
Shorla acquires methotrexate solution from Therakind in the US

Shorla Oncology has acquired the oncology and autoimmune drug Jylamvo (methotrexate) from Therakind, for commercialisation in the US market. Jylamvo was approved by the US Food and Drug Administration (FDA) approval in November 2022, to treat adults with acute lymphoblastic leukaemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis. Shorla is headquartered in Ireland and has operations in the US. The company had raised $35m earlier this month to advance its oncology pipeline. Jylamvo is an oral solution, making the treatment accessible to patients who may struggle taking tablets or other dosage forms. Commercialisation is set to begin immediately in the US. Chief Technical Officer and founder of Shorla Oncology Orlaith Ryan said: “This acquisition will provide a much-needed treatment to patients in need. It brings a crucial oral treatment to a larger patient population who suffer from cancer and other debilitating illnesses.” In March, Shorla ...
- Source: drugdu
- 106
- November 2, 2023

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