PharmaFocus Today – Page 224 – media

BD hires new chief medical officer from 3M Health Care

BY JIM HAMMERAND Dr. Ron Silverman is the next chief medical officer of Becton, Dickinson & Co. [Photo courtesy of BD] Becton, Dickinson & Co. (NYSE: BDX)+ today named Dr. Ronald “Ron” Silverman as EVP and chief medical officer. He replaces BD Chief Medical Officer Dr. William Sigmund, who announced plans to retire from BD earlier this year. The change takes effect Dec. 4, 2023. Silverman comes from 3M Health Care, where he served as SVP and chief medical officer since 2021. He will lead BD’s medical affairs organization across BD’s business units, regions and central team. Franklin Lakes, New Jersey-based BD said Silverman “will use medical insights and expertise to advance BD’s pipeline of clinically relevant, innovative solutions that align with evolving patient needs, while also contributing to the safety and compliance of BD’s in-market portfolio of products.” Silverman will report to BD EVP and Chief Technology Officer Beth ...
- Source: drugdu
- 96
- November 27, 2023
White Bagging Policies Endanger the Lives of Cancer Patients

Insurers and PBMs are increasingly implementing white-bagging policies, which require oncology practices to obtain physician-administered infusions and other medications from designated specialty pharmacies often owned by or affiliated with insurers and their PBMs. By DR. JAMAL MISLEH Earlier this year, a young man in his mid-thirties with non-Hodgkin’s Lymphoma came to my oncology clinic for a chemotherapy infusion while waiting on the development of his CAR-T treatment. Under normal circumstances, our practice can move quickly when scheduling patients for their treatments since our in-office infusion clinic maintains an inventory of necessary medications that we prepare ourselves onsite. But, unbeknownst to me, my patient’s health insurance plan included a policy called “white bagging,”- a policy which we soon discovered when they denied one of the chemotherapy drugs I prescribed. Our clinical team repeatedly appealed the denial; however, the plan refused to cover the drug unless it was fulfilled through an unspecified ...
- Source: drugdu
- 96
- November 27, 2023
report

After many months of shortages affecting attention-deficit/hyperactivity disorder (ADHD) drugs, it was hoped that new generics to Takeda’s Vyvanse would ease the supply situation. But according to a letter from the Association for Accessible Medicines (AAM), production limits on the drug’s active ingredient—set by the government—are at least partly to blame for the shortage that has spread to the generics. Generic drugmakers haven’t been able to obtain enough raw material to “launch their products at full commercial scale,” AAM wrote to the Drug Enforcement Administration (DEA), according to Bloomberg. The DEA sets specific restrictions on production to avoid an excess of supply that could spread to the black market due to Vyvanse’s status as a controlled substance. The agency sets its limits based on past production levels and future sales commitments, which poses a problem given that some companies are cleared to launch the generics but haven’t sold any so ...
- Source: drugdu
- 258
- November 26, 2023
FDA fast tracks Alladapt’s multi-food allergy immunotherapy

The US Food and Drug Administration (FDA) has granted a fast track designation to Alladapt Immunotherapeutics’ IgE-mediated multi-food oral immunotherapy ADP101. The FDA’s decision was based on the results from the Phase I/II Harmony trial, which investigated the immunotherapy’s use in inducing desensitisation in patients with single or multiple food allergies, including nuts, dairy, seafood and more. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling and priority reviews. In this instance the designation allows Alladapt to seek accelerated approval for oral immunotherapy in paediatric patients, aged between four and 17 years, with one or more of the 15 food allergies covered by ADP101, as per a 22 November press release. Phase I/II data The double-blind, placebo-controlled Phase I/II Harmony trial (NCT04856865) enrolled 61 paediatric patients (aged four-17 years) and 12 adult patients (aged 18-55 years). The ...
- Source: drugdu
- 214
- November 26, 2023
Simcere and Connect sign licensing agreement for anti IL-4Rα AD drug

Simcere has entered a licensing agreement with Connect Biopharma for the development of a monoclonal antibody (MAb) candidate rademikibart (CBP-201) against allergic inflammation in autoimmune conditions such as atopic dermatitis (AD) and asthma. Under the deal, the Nanjing, China-headquartered company will have a licence for the development and commercialisation of rademikibart in mainland China, Macau, Taiwan, and Hong Kong. Connect retains its rights to the MAb outside Greater China. Rademikibart is a humanIgG4 MAb that binds to IL-4Rα, which can be administered as a subcutaneous or intravenous (IV) injection. Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has dominated the AD drug market since it first gained a US Food and Drug Administration (FDA) approval in March 2017. Dupixent had generated $6.4bn in US sales up until 30 September, according to Regeneron’s Q3 2023 report. It is forecast to make over $11bn in global sales for all indications by the end of ...
- Source: drugdu
- 189
- November 26, 2023
EirGenix and Sandoz win EU approval for Herceptin biosimilar

The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
- Source: drugdu
- 176
- November 26, 2023
Flagship-Founded Microbiome Company Evelo Biosciences Throws in the Towel

By Kate Goodwin Pictured: Closed sign/iStock, StockSeller_ukr After a couple of disappointing years, a microbiome biotech founded by Flagship Pioneering is calling it quits. In an SEC filing Monday, Evelo Biosciences reported that dissolution is “in the best interest” of the company as well as its creditors and stockholders. The company was launched in 2015 by Flagship to develop inflammation-resolving microbe medicines to act on cells in the small intestine with systemic therapeutic effects for inflammatory diseases. However, the past two years have been tough for Cambridge, Mass.-based Evelo as one by one each of its assets disappointed. After a Phase II failure in April 2022, its second atopic dermatitis candidate in Phase II testing did not meet the trial’s primary endpoint in February 2023. The company pointed to an unusually high placebo response rate. The results sent Evelo’s stock tumbling 50% at the time and the company cut around ...
- Source: drugdu
- 170
- November 25, 2023
Darzalex Faspro in Multiple Myeloma, Imbruvica-Venclexta in Mantle Cell Lymphoma

By Tristan Manalac Ahead of the 65th Annual Meeting and Exposition of the American Society of Hematology, taking place Dec. 9 to 12, event organizers on Tuesday released late-breaking abstracts providing an early view of some of the most high-impact studies in blood disorders to be presented at the conference. Focus on two of those studies below. J&J, Genmab’s Darzalex Faspro Early data from the Phase III PERSEUS study showed that J&J and Genmab’s subcutaneous anti-CD38 antibody Darzalex Faspro (daratumumab and hyaluronidase-fihj) significantly prolonged progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM). PERSEUS enrolled 709 patients in total, of whom 355 were randomly assigned to receive Darzalex Faspro combined with bortezomib, lenalidomide and dexamethasone (VRd). At a median follow-up of 47.5 months, patients treated with the Darzalex Faspro regimen saw a significantly better PFS versus comparators who received VRd alone. The effect had a hazard ratio of ...
- Source: drugdu
- 119
- November 25, 2023
White Bagging Policies Endanger the Lives of Cancer Patients

Earlier this year, a young man in his mid-thirties with non-Hodgkin’s Lymphoma came to my oncology clinic for a chemotherapy infusion while waiting on the development of his CAR-T treatment. Under normal circumstances, our practice can move quickly when scheduling patients for their treatments since our in-office infusion clinic maintains an inventory of necessary medications that we prepare ourselves onsite. But, unbeknownst to me, my patient’s health insurance plan included a policy called “white bagging,”- a policy which we soon discovered when they denied one of the chemotherapy drugs I prescribed. Our clinical team repeatedly appealed the denial; however, the plan refused to cover the drug unless it was fulfilled through an unspecified designated specialty pharmacy associated with the patient’s pharmacy benefit manager. Eventually, we were able to negotiate coverage through our practice’s internal inventory, but by the time the patient was able to receive the drug four weeks had ...
- Source: drugdu
- 149
- November 25, 2023
Breakthrough decoding of the Y chromosome revolutionizes digestive disease research

A major breakthrough in human genetics has been achieved with the complete decoding of the human Y chromosome, opening up new avenues for research into digestive diseases. This milestone, along with advancements in third-generation sequencing technologies, is poised to revolutionize our understanding of the genetic underpinnings of digestive disorders and pave the way for more personalized and effective treatment strategies. The Y chromosome, the smallest of the human chromosomes, has long been shrouded in mystery due to its complex repetitive structure. However, recent advancements in sequencing technologies have enabled researchers to unravel the intricate details of this genetic region, shedding light on its role in sex determination and its potential impact on various diseases, including those affecting the digestive system. Completing the Y chromosome sequence provides a comprehensive reference for identifying genetic variations that may contribute to digestive diseases. This information is crucial for understanding the “missing heritability” problem, where ...
- Source: drugdu
- 191
- November 25, 2023

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