// Biotech and Pharma Therapeutics

J&J wins approval of new kind of multiple myeloma drug
October 26, 2022 / J&J / New Drug / Drug Approval / FDA – Tecvayli is part of a growing group of drugs that target a protein called BCMA found on malignant cells in multiple myeloma. GlaxoSmithKline was the first to market with a treatment aimed at BCMA, after winning FDA clearance for the antibody-drug conjugate Blenrep in 2020. Abecma also targets BCMA, but it’s a CAR-T therapy that’s produced using a patient’s own T cells. J&J sells a CAR-T treatment of its own for multiple myeloma, called Carvykti. However, its newest medicine can be used “off the shelf,” rather than the personalized manufacturing process needed in cell therapy. It’s known as a bispecific therapy and is the first to target BCMA while also binding to the CD3 receptor on T cells. Bringing the cancerous and protective cells together helps spur the immune system into action to curb cancer growth. Read Full Article on Biopharma Dive>>
For Biogen investors, company’s outlook rests on next Alzheimer’s drug October 25, 2022 / Alzheimer’s / Investors / Biogen – Biogen, in what’s become a pattern over the past two years, spent much of its latest earnings presentation Tuesday answering questions about how a closely watched drug for Alzheimer’s disease could help the beleaguered company rebound. Until recently, analysts and investors were focused on Aduhelm, a Biogen medicine that, in June 2021, became the first Food and Drug Administration-approved treatment for what’s believed to be an underlying cause of Alzheimer’s. Despite that title, Aduhelm sales have been anemic, as major insurers balked at the medicine’s price and the contradictory data that supported its clearance. Read Full Article on Biopharma Dive>>
GSK dumps major pipeline prospect otilimab on lackluster phase 3 data in rheumatoid arthritis October 27, 2022 / GSK / Rheumatoid Arthritis –GSK has dumped one of its top pipeline prospects. While two of the three phase 3 trials of otilimab hit their primary endpoints, the Big Pharma concluded the efficacy fell short of the level needed to take the anti-GM-CSF antibody forward in rheumatoid arthritis (RA). Last year, GSK identified otilimab as a potential blockbuster that formed part of a late-stage pipeline with potential peak sales in excess of 20 billion pounds sterling ($23 billion). The company moved into phase 3 and forecast blockbuster sales despite a phase 2 clinical trial of the candidate missing its primary endpoint and other developers of anti-GM-CSF antibodies stopping work in RA. Read Full Article on Fierce Pharma>>
GSK’s oral anemia drug bruised with FDA panel partial snub in chronic kidney disease October 26, 2022 / FDA advisory committee / GSK / daprodustat / Anemic Chronic Kidney Disease –Following two FDA rejections of novel oral anemia drugs, all eyes are on GSK’s daprodustat. Now, the drug has come out of an FDA panel meeting partially bruised, losing experts’ support in one of the two patient populations that it’s seeking approval for. After heated discussions during a Wednesday meeting, an independent FDA advisory committee voted 11-5 that the benefit of GSK’s daprodustat doesn’t outweigh its risk in patients with chronic kidney disease-related anemia who are not on dialysis, Read Full Article on Fierce Pharma>>
Solera Health Launches First-of its-kind Women’s Health Offering for Payers & Employers October 27, 2022 / Solera Health / Women’s Health –Solera conducted extensive user research and found that 68% of women agree that women’s health doesn’t get enough attention. Furthermore, 87% of women are very or extremely interested in at least one of the tools Solera offers and 79% would like to use more than one solution at the same time, indicating that one size does not fit all for women’s health. Solera’s Women’s Health Network will begin with five partner solutions: Frame Fertility, Origin, Pacify, RestoreBalance and Visana. This network has been carefully vetted and curated to bring the best possible solutions together in one place to address women’s physical, behavioral, and social needs at each life stage. These solutions serve as a strong complement to leading maternal offerings to help a health plan or employer better serve the needs of all women in its population through a single contract and IT integration.Read Full Article on HIT Consultant >>

// 4th Industrial Revolution

A New Smart Pill Design Delivers Complex Drugs by Boring
October 25, 2022 / Smart Pill / New Drug / MIT – A study published in Science Robotics demonstrates a novel drug capsule devised at MIT that incorporates a robotic cap that rotates and burrows through the mucus barrier as it enters the small intestine, enabling drugs carried by the capsule to enter the intestinal cell lining. The mucus displacement can boost the drug distribution in a localized region, thereby enhancing the assimilation of both small molecule and macromolecule pharmaceuticals. The researchers asserted that they could employ this technique to orally administer insulin and vancomycin (an injectable antibiotic). The basic concept of developing a protective capsule with a mechanism capable of tunneling through mucus is similar to how tunnel-boring machines bore into earth and rock. When ingested, the coating dissolves within the digestive tract, and the change in pH causes a small motor within the RoboCap capsule to spin. Furthermore, the capsule is also covered with little studs or pegs that, like a toothbrush, sweep mucus away. Read Full Article on Health Tech Insider >>
Sony Now Offers Over-The-Counter Hearing Aids
October 25, 2022 / Sony / Hearing Aids / Over-The-Counter / New Tech – Sony developed the CRE-C10 and CRE-E10 self-fitting OTC hearing aids in partnership with WS Audiology (WSA). WSA is a long-established hearing aid manufacturer with headquarters in Denmark and Singapore. The Sony devices both feature easy set-up and discrete use. The CRE-C10 and CRE-E10 are both intended for daily wear. According to the Sony news release, users can personalize the hearing aid settings easily with Sony’s Hearing Control App, available for iOS and Android devices. There’s AI in the fitting process as the hearing aids self-adjust with pre-defined hearing profiles derived from thousands of real-life audiograms. When the user wears the configured hearing aids in daily life, the profile automatically adapts to different sound environments.
Full Article on Health Tech Insider >>
Bon Secours Mercy Health uses AI and automation to empower talent recruiters
October 27, 2022 / Mercy Health / AI / Automation –To do that most effectively, the health system must be staffed properly with employees who thrive within the mission of service and share the passion to be leaders in delivering high-quality compassionate healthcare, said Eric Van Duren, chief talent acquisition officer at Bon Secours Mercy Health. McKinsey predicts that by 2025 the United States could have a shortage of 450,000 nurses available for direct patient care. Read Article on Health Care IT News >>
Deep-Learning Algorithm Can Detect Cancer Spread Following Surgery
October 27, 2022 / Cancer Detecting / New Algorithm / Cancer Research – A study conducted by ECOG-ACRIN Cancer Research Group found that using a deep-learning algorithm that leverages standard computed tomography (CT) scan images showed promise in assessing cancer spread risk among those with head and neck cancer. Researchers noted there was a high degree of morbidity associated with standard head and neck cancer treatment. The previously conducted E3311 Phase 3 clinical trial found that low-dose radiation at 50 Gray without chemotherapy following transoral surgery provided positive results. Read Full Article on Health IT Analytics >>
Deep-Learning Tool May Facilitate Monkeypox, Skin Disease Identification
October 26, 2022 / Skin Disease Identification / Monkeypox / CDC / WHO –On July 23, the World Health Organization (WHO) declared the 2022 global monkeypox outbreak a Public Health Emergency of International Concern (PHEIC) following reported cases of the disease in 75 countries. Shortly afterward, in August, the US Department of Health and Human Services (HHS) declared the ongoing spread of the disease across the country a public health emergency (PHE). Monkeypox is a smallpox-like disease characterized by fever, chills, headache, swelling of the lymph nodes, muscle aches, fatigue, respiratory symptoms, and painful skin eruptions, according to the Centers for Disease Control and Prevention (CDC). People with monkeypox also get a rash that can initially appear to be painful or itchy pimples and blisters but will progress through several stages, including scabs, before finally healing. Read Full Article on Health IT Analytics >>
The Gains and Pains of Using AI in the Pharmaceutical Industry
October 25, 2022 / AI / Pharma Industry –The costs for drug discovery and development are skyrocketing, but AI (artificial intelligence) is introducing new efficiencies to help find effective treatments faster. A study in 2020 concluded that the estimated median capitalized research and development cost per product was $985 million. Contributing factors to this included larger trial sizes, the need to assess health technology, the requirement to provide data on comparative drugs’ effectiveness, and most importantly the high failure rate. Seven out of eight compounds that enter the clinical testing pipeline are never developed. Read Full Article on HIT Consultant >>

// Business & Markets

Novartis sales of Zolgensma gene therapy slow as market shifts
October 25, 2022 / Novartis / Gene Therapy / Market Shift – Sales of Novartis’ gene therapy Zolgensma declined in the third quarter as use of the medicine has mostly shifted to infants newly diagnosed with the neuromuscular disease it treats. Between July and September, global sales totaled $319 million, down 16% from the previous quarter and 15% from the same period last year, according to financial numbers disclosed by Novartis Tuesday. Both the U.S. and non-U.S. markets now predominantly involve “incident” disease treatment, rather than of already diagnosed patients, Novartis said. Read Full Article on Biopharma Dive >>
Merck & Co. ditches oncolytic virus Cavatak 4 years after buying Viralytics
October 27, 2022 / Merck & Co. / Viralytics / Moderna / Earnings –Merck & Co. is bidding adieu to the oncolytic virus acquired from its 2018 purchase of Viralytics, with the pipeline change disclosed weeks after the Big Pharma hitched its wagon onto Moderna’s cancer vaccine program. Read Full Article on Fierce Biotech >>
Pfizer under Italian finance probe over alleged $1.2B profits offshoring: Bloomberg
October 27, 2022 / Pfizer / Italy / Offshoring – In a new investigation, Italy’s finance authorities allege that Pfizer’s Italian unit, Pfizer Italia Srl, hid profits of at least 1.2 billion euros ($1.2 billion) by transferring money to Pfizer units in other countries, Bloomberg reports from people familiar with the investigation. Specifically, the allegations reportedly say that Pfizer Italia Srl transferred “excess capital” to Pfizer affiliates in the U.S. and the Netherlands to avoid taxes that could be as high as 26%. The investigation began this February and covers 2017, 2018 and 2019, the people told Bloomberg. In those three years, Pfizer’s global adjusted net profit reached $33 billion. Read Full Article on Fierce Pharma >>
In defense, Merck CEO and soon-to-be chairman Davis touts progress in his tenure
October 27, 2022 / Merck / Keytruda / Robert Davis / Ken Frazier – Another reminder came four minutes later as Li talked about an HIV drug in development. The warnings were an appropriate intrusion considering the clock that is ticking on Merck and its bell cow Keytruda, whose sales of $5.4 billion accounted for 36% of the company’s revenue in the quarter. With the cancer superstar expected to lose its patent protection in 2028, there’s an elephant in the room until the company identifies suitable replacements.Read Full Article on Fierce Pharma >>
Greenway Incorporating Health Equity Features into its EHR
October 25, 2022 / Greenway / EHR / Health Equity – Addressing health equity starts with meeting patients where they are. This means, for example, offering treatment and medication options that are suited to the patient’s current situation (socioeconomic status, transportation availability, location, etc.). The natural place to capture and display this type of information is in the Electronic Health Record (EHR). Greenway Health, a leading ambulatory EHR provider, has added new features to accommodate this non-medical information and make recommendations based on that data. Read Full Article on Healthcare IT Today >>

// Legal & Regulatory

BioMarin to face FDA advisers before approval decision on hemophilia gene therapy
October 27, 2022 / BioMarin / FDA / Gene Therapy – Tucked into its latest earnings report, BioMarin Pharmaceutical said that the Food and Drug Administration plans to convene a group of outside advisers to assess the company’s gene therapy for hemophilia. BioMarin said it has not yet been given a date for when this advisory committee meeting will take place. The company officially resubmitted the approval application for its treatment, called Roctavian, to the FDA in late September, and expects a verdict by the end of March. Read on Biopharma Dive >>
FDA advisers split vote on GSK kidney disease drug, complicating regulatory path
October 27, 2022 / FDA / Split Vote / GSK Kidney Disease –The partial recommendation may be enough for GSK to sell the first anemia pill in the U.S. for chronic kidney disease patients, even if it’s for a smaller market than the British drugmaker had sought. In a little more than a year, the FDA has rejected two other anemia pills, developed by FibroGen and Akebia Therapeutics, because of concerns about heart-related side effects. Given the earlier rejections, the mixed result from the FDA committee “is probably better than widely anticipated,” Jefferies analyst Peter Welford wrote in a note to investors. He estimates the drug could have peak sales of $1 billion, largely based on its use in dialysis patients alone. Read on Biopharma Dive >>
Seres one step closer to bringing first oral microbiome therapy to market as FDA mulls approval
October 26, 2022 / Seres Therapeutics / Microbiome / Clostridium Difficile – The FDA will review Seres’ application for SER-109’s approval to treat Clostridium difficile infection, without an advisory committee meeting likely to be required, the company said in an Oct. 26 release. An approval decision is expected by April 26. It marks some welcome good news for Cambridge, Massachusetts-based Seres, which saw its shares plummet last year after ulcerative colitis candidate SER-287 flopped against placebo in a phase 2 trial. SER-109 hasn’t had a smooth ride either, having previously failed to cut the risk of C. difficile infection in a phase 2 trial back in 2016. Still, the biotech had pinned its hopes on the therapy following a strategic pivot and a 30% workforce cut in 2019. Read on Fierce Biotech >>
FDA keeps Jazz’s lung cancer accelerated approval in place—for now—despite failed trial and calls for withdrawal
October 26, 2022 / Jazz Pharmaceuticals / US FDA / Accelerated Approval / Small Cell Lung Cancer – Even when a drug’s confirmatory trial fails, the FDA may still give companies a second chance before pulling accelerated approvals. Jazz Pharmaceuticals’ lung cancer drug Zepzelca is the latest to be granted that mercy, though not without some objections. The FDA has turned down a citizen petition by law firm Foley Hoag that had asked the agency to pull Zepzelca’s accelerated approval in previously treated small cell lung cancer (SCLC). Read on Fierce Pharma >>
OTC birth control pill delayed as FDA postpones expert meeting for Perrigo drug
October 26, 2022 / Perrigo / Oral Contraceptive / Birth Control / Women’s Health –Women who are looking to get birth control medication without a prescription will have to wait longer than previously expected. The FDA has pushed back a decision date on a proposed over-the-counter switch of Perrigo’s prescription birth control drug Opill by 90 days, Perrigo said Wednesday. Perrigo had previously expected an approval in the first half of 2023, but the exact original FDA action date was never disclosed. Perrigo’s HRA Pharma applied for the Rx-to-OTC switch on July 11, and such reviews typically take 10 months. Read on Fierce Pharma >>

// Research & Development

GSK shelves filing plans for arthritis drug after trial results
October 27, 2022 / GSK / Arthritis / Trial Results – GSK on Thursday said it has decided to shelve plans to seek approval of an experimental drug in rheumatoid arthritis after results from a Phase 3 trial fell short of its study goals. The British drugmaker had been preparing to file an approval application for the drug, called otilimab, next year after positive results in two prior studies. GSK licensed the antibody drug from Morphosys in 2013 and, since then, it’s become a top prospect for the company, which previously forecast future peak yearly sales of between 1 billion and 2 billion pounds. Read Full Article on Biopharma Dive >>
AstraZeneca extends run of trial successes with breast cancer drug results
October 26, 2022 / AstraZeneca / Breast Cancer / Drug Results – AstraZeneca on Wednesday said two experimental breast cancer drugs showed promise in separate clinical trials, succeeding in areas where the British drugmaker’s rivals have fallen short. One drug, called capivasertib, met both of its goals in a Phase 3 trial of patients with breast cancer whose tumors are hormone positive, but have low or no detectable levels of a protein called HER2. The other, camizestrant, achieved its objective in a smaller, Phase 2 study of post-menopausal patients with metastatic, estrogen receptor-positive disease. Read Full Article on Biopharma Dive >>
RTLS helps enhance contact tracing of high-risk COVID-19 cases, South Korean study finds
October 21, 2022 / RTLS / COVID-19 / South Korean University – The study identified over 1,000 contact cases of confirmed COVID-19 patients in the first quarter of the year. The findings, which have been published in the Journal of Medical Internet Research, revealed that the RTLS has higher sensitivity in detecting high-risk contact cases (60%) compared to a conventional contact tracing method (46.8%), which involves an in-person interview and a review of EMR and surveillance camera feeds. Moreover, the RLTS has shown an 8.1% secondary transmission rate among the identified cases while the conventional method has shown 5.3%. Read Full Article on Healthcare IT News >>
Exelixis announces results from trial evaluating XB002
October 27, 2022 / Exelixis / XB002 / Trial Results – Exelixis has announced promising initial results from the ongoing dose-escalation stage of JEWEL-101 – a phase 1 study evaluating XB002, the company’s next-generation tissue factor-targeting antibody-drug conjugate. The data was presented at ENA 2022 during the Symposium on Molecular Targets and Cancer Therapeutics hosted by the European Organisation for Research and Treatment of Cancer, the National Cancer Institute and the American Association for Cancer Research. Read Full Article on PharmaTimes >>
NHS to offer epilepsy patients brain laser therapy
October 24, 2022 / NHS / Epilepsy / Brain Laser Therapy – The first surgeries are set to take place in early 2023 and potentially benefit up to 150 NHS patients each year, offering hope to thousands of people living with the condition. The fibre optic laser requires a 1.5mm-wide probe into the skull and destroys the brain tissue which causes epilepsy from the inside by using heat. The treatment uses an MRI scanner and the specialist clinical team carefully navigates through the brain, avoiding blood vessels and other critical structures, while also monitoring the temperature of the surrounding areas to ensure healthy brain tissue does not overheat. Read Full Article on PharmaTimes >>

// Politics

What does Biden’s directive on foreign biotech investments mean for manufacturers?
October 27, 2022 / Biden / Foreign Biotech / Investment – The increasing regulation of biotech and manufacturing deals in the US could prompt foreign companies such as Chinese contract development and manufacturing organisations (CDMOs) to seek alternative targets in Europe or elsewhere. On 15 September, US President Joe Biden signed an executive order that targets foreign investments in US biotech, artificial intelligence (AI), semiconductors and other sensitive technologies. This could have wide-reaching effects on emerging pharmaceutical markets such as China, which are seeking to acquire innovative pharma manufacturing expertise in the US. Biden’s executive order defines national security factors for the existing Committee on Foreign Investment in the United States (CFIUS) to consider when evaluating transactions, specifically a deal’s effect on critical US supply chains, US technological leadership in biotechnology, cybersecurity risks, or risks to US persons’ sensitive data. Read Full Article on Pharmaceutical Technology >>
Mexico quietly ruling on GMO traits as biotech corn ban looms
October 26, 2022 / Mexico / GMO / Biotech – Mexico has not publicly ruled on genetically modified plant traits in the four years since President Andrés Manuel López Obrador took power, but the country’s health regulator Cofepris has been quietly approving and rejecting traits with an apparent bias against glyphosate-resistant corn seeds, according to U.S. government and industry sources. The situation is especially vexing to the U.S. corn sector, which already faces significant financial peril because of a Mexican ban on GMO corn that is set to take effect in about a year, just as farmers are taking their 2023 crop to market. Mexico was the largest foreign corn market last year for the U.S., which sent roughly 25% of its exports to Mexican buyers. Read Full Article on Agri Pulse >>
The U.S. Must Take Action on China’s National Security–Related Life Sciences Programs
October 24, 2022 / US / China / Life Sciences – The People’s Republic of China (PRC) has one of the world’s most advanced life sciences R&D enterprises. Beijing is clearly driven to become the world’s biotechnology leader for a variety of reasons, including national security purposes. Beijing’s national “military-civilian fusion” policy means that work in the life sciences for peaceful civilian ends could support belligerent military, intelligence, and other national security applications and policies. The PRC’s dual-use ambitions in the life sciences will have consequences for U.S. national interests. Considering the PRC’s prodigious geopolitical aspirations, unprecedented military build-up, and revisionist vision of global politics, Beijing’s potential use of the life sciences, especially biotechnology, requires significant action from U.S. policymakers. Read Full Article on The Heritage Foundation >>
Government regulation and information presentation may determine palatability of the concept of gene-edited food
October 26, 2022 / Government Regulation / Gene-edited – The researchers analyzed the public perceptions of the risks and benefits of gene editing of food crops in the United States, Japan, and Germany. They found that of these groups, American participants had the most positive perception and German participants the most negative, with Japanese participants assessing the risks similarly to the Germans but the benefits similarly to the Americans. Read Full Article on Phys.Org >>