// Biotech and Pharma Therapeutics

Lilly’s tirzepatide slides into FDA fast lane for obesity, turning up heat on Novo Nordisk’s Wegovy
October 6, 2022 / Eli Lilly / Tirzepatide / Mounjaro / U.S. FDA –Thursday, Lilly said the FDA flagged its drug for fast-track designation in adults with obesity plus those who are overweight with weight-related health problems. The decision puts pressure on Novo Nordisk and its own weight loss arriviste Wegovy, which largely has the obesity market to itself for now. Novo’s blockbuster-to-be, which forms part of the Danish drugmaker’s semaglutide franchise, won a landmark obesity approval last summer. Wegovy has stumbled on supply issues tied to unexpected demand and early contract manufacturing problems, though Novo says the problems are mostly in the rearview. Wegovy pulled down 1.18 billion Danish kroner ($161 million) in 2022’s second quarter. Read Full Article on Fierce Pharma >>
J&J, Legend double CAR-T manufacturing investment to $500M as Carvykti eyes wider myeloma use October 6, 2022 / Legend Biotech / Johnson & Johnson / CAR-T / Cell & Gene Therapy –J&J and Legend will double investment in their Raritan, New Jersey, manufacturing facility, bringing the total to $500 million, Legend CEO Ying Huang, Ph.D., told investors during a conference Monday. The cell therapy manufacturing site currently makes Carvykti for the U.S. Together with another factory under construction in Ghent, Belgium, J&J and Legend in the next few years “will be in a position to have a capacity that accommodates the $5 billion-plus peak sales projected by J&J,” Huang said. Read Full Article on Fierce Pharma >>
After years of manufacturing woes, Takeda is calling it quits on Natpara October 4, 2022 / Takeda / Shire / Natpara / Rare Diseases –The Japan-based pharma has elected to nix all manufacturing of its Natpara injection for hypoparathyroidism in the U.S. and abroad by the end of 2024, a decision it credited to “unresolved supply issues that are specific to the product.” In the wake of that manufacturing halt, Takeda says it won’t put Natpara back on the market in the states or make the drug anywhere else globally. Natpara, known generically as parathyroid hormone, is marketed under the Natpar brand internationally. Takeda acquired the rare disease med in its $62 billion buyout of Shire. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

Optimising patient and clinician experiences through HIE
October 4, 2022 / HIE / Healthcare – At Samsung Medical Center in South Korea, an HIE infrastructure is promoting medical care efficiency while improving both patient and clinician experiences. Called DARWIN (Data Analytics and Research Window for Integrated Knowledge), this HIS is able to share medical records safely and electronically in real time with external institutions. Through this system, SMC is exchanging documents, such as medical requests, medical referrals, medical record summaries, and radiology reading opinions, complying with HL7 CDA standards. This allows clinicians to find patients’ histories quickly, reducing the risk of overprescribing or duplicating prescriptions. Read Full Article on Healthcare IT News >>
Using AI to fight drug-resistant infections
October 4, 2022 / AI / Drug-resistant infections / Digital Health Care –As antimicrobial-resistant infections are set to overtake cancer as the top global health risk by 2050, the world needs to quickly find a solution that will help in detecting and reducing its risk of mortality while bringing down the economic cost. During the keynote session, “Digital Transformation of Health Care: Intelligent Anti-Microbial System (iAMS),” at HIMSS22 APAC, Dr Der-Yang Cho, professor and superintendent of China Medical University Hospital, emphasised the importance of developing a new generation of antibiotics using emerging technologies. “Antimicrobial stewardship and development of a next-generation of antibiotics are very important and very critical,” he said, noting that AMRs claim 4.7 million lives in Asia each year. Full Article on Healthcare IT News >>
MIT, MGH create VR system to advance physical therapy at home
October 6, 2022 / VR / MIT / Physical Therapy –MIT and Massachusetts General Hospital researchers created a motion and muscle engagement monitoring system for unsupervised physical rehabilitation, which could help with injuries and better mobility for the elderly and athletes, they say. Read Article on Healthcare IT News >>
Telehealth now serves unmet needs, says athenahealth
October 4, 2022 / Telehealth / Athenahealth –New research, based on a Dynata survey of 2,000 U.S. adults that was commissioned by athenahealth conducted in June and July of this year, and data on booked and completed appointments through the athenahealth electronic health record suggest telehealth is now integrated across the care continuum. “Our data shows that after the height of the pandemic, many physicians continue to rely on telehealth, as they see the tremendous value it can provide,” said Jessica Sweeney-Platt, vice president of research and editorial strategy at athenahealth, in a statement. Read Full Article on Healthcare IT News >>
Personalising care through digitally-enabled care models October 4, 2022 / Digital Health / Healthcare –Future health systems must “shift towards a more outcome-focused, equitable health system to ensure every person everywhere has access to care to realise their full health potential,” said Dr Anne Snowdon, Chief Scientific Research Officer at HIMSS Analytics, during her presentation at HIMSS22 APAC. In the keynote session, “Digital Health Transformation as a Strategy to Advance Equity in Global Health Systems,” Dr Snowdon said “meaningful digital connectivity with care teams” will help build health literacy and empower patients to make data-driven decisions about their health. Read Full Article on Healthcare IT News >>
GSK hits go on pivotal TIM-3 lung cancer trial after phase 2 clears bar for advancement October 5, 2022 / GSK / Non-small Lung Cancer / Immuno-oncology / Checkpoint Inhibitors – TIM-3 is a checkpoint receptor and the latest in a series of targets that have caught the imagination of the immuno-oncology sector. With interest in TIGIT, another checkpoint receptor, on the rocks after the failure of Roche’s candidate, TIM-3 could now step into the limelight. But companies still need to deliver data to show it can avoid the doomed fates of previous red-hot immuno-oncology targets. GSK took a step toward potentially validatory data Wednesday, revealing that both arms of its phase 2/3 non-small cell lung cancer (NSCLC) clinical trial have met the criteria for advancing into the next stage of the study. Read Full Article on Fierce Biotech >>

// Business & Markets

Lilly inks $425M biobuck drug discovery pact with Schrödinger
October 6, 2022 / Eli Lilly / Schrodinger / Drug Discovery / Small Molecules – Schrödinger has landed deals with companies including Bristol Myers Squibb and Sanofi on the strength of its physics-based computational platform. Using the machine-learning-enabled platform, Schrödinger can test billions of molecules in computational assays and, it claims, half the time taken to deliver a drug development candidate while improving on the properties achieved using traditional design processes. Read Full Article on Fierce Biotech >>
Spying a devilish deal, AstraZeneca pays 666% premium to buy genomic medicine biotech
October 3, 2022 / Alexion / AstraZeneca / LogicBio Therapeutics / Cell & Gene Therapy – LogicBio has endured a tough 12 months, in which news of a clinical hold has combined with the broader biotech bear market to drag its stock down by 94% to 27 cents. While the FDA later lifted the clinical hold, the effect on the stock stuck. And, with the biotech’s cash reserves expected to run dry in the second quarter of 2023, that presented management with a problem. The rock-bottom share price caught the attention of AstraZeneca’s Alexion, which has identified genomic medicine as a growth area for its rare disease business. Alexion has agreed to buy LogicBio for $2.07 per share, a 666% premium over the closing price yesterday but a steal by historical standards. Read Full Article on Fierce Biotech >>
Nearing a ‘watershed’ year, biosimilar industry gets a boost from Inflation Reduction Act
October 6, 2022 / Biosimilars / Centers for medicare & Medicaid Services (CMS) / Department of Health and Human Services / Coherus – The new IRA measure—which hasn’t received much fanfare—came into effect on Monday and will remain in place for five years. It establishes an 8% add-on fee that Medicare Part B will pay (PDF) healthcare providers for qualifying biosimilars, replacing the previous 6% markup. Julie Reed, executive director of the Biosimilars Forum, hailed the new policy, saying it “will increase competition, promote access and ultimately save American taxpayers and patients money.” Pointing to a study by IQVIA, Reed said in a statement that increasing the add-on payment for some biosimilars in the U.S. could reduce healthcare costs by up to $8.2 billion over the next decade. Read Full Article on Fierce Pharma >>
Cytiva expansion tear continues with CEVEC Pharma acquisition
October 6, 2022 / Cytiva / Mergers and Acquisitions / Viral Vectors / Cell & Gene Therapy – The acquisition gives Massachusetts-based Cytivia access to scalable production cell lines for vectors based on adeno-associated viruses and adenoviruses, which are two of the most widely used vectors for delivering therapeutic genes to target cells and tissues. The technology will help Cytiva keep up with the increasing demand in the industry for volume and consistent quality of viral vectors, according to an Oct. 6 press release. “With Cytiva’s global reach and ability to scale, more customers will have access to CEVEC’s technology and expertise to help accelerate and advance therapeutics for the benefit of patients,” Emmanuel Abate, Cytivia’s president of genomic medicine, said in the press release. Read Full Article on Fierce Pharma >>
In $500M expansion, Merck opens one Singapore facility and breaks ground on another October 5, 2022 / Merck / Gardasil / Keytruda / Prefilled Syringe – Wednesday, the New Jersey-based company opened a new secondary packaging facility to churn out vaccines and biologics. It also broke ground on a plant that will produce inhalers and is set for completion in 2026. Merck’s fill-finish facility in Singapore now includes a vial-packaging line to produce cancer treatment Keytruda and three syringe-packaging lines to manufacture another Merck mega blockbuster, HPV vaccine Gardasil. The site began the sterile fill of Keytruda into vials last year. Its expansion includes cold storage and a new quality control laboratory. Read Full Article on Fierce Pharma >>

// Legal & Regulatory

TauRx’s Alzheimer’s trial failed to deliver the pre-specified analyses. It plans to seek approval anyway
October 6, 2022 / Alzheimer’s Disease / Alzheimer’s Drugs / TauRx / Anti-Tau –U.K.-based TauRx randomized 598 people, with symptoms ranging from mild cognitive impairment to moderate Alzheimer’s, to receive its inhibitor of tau aggregation or placebo. Because the study drug, hydromethylthionine mesylate (HMTM), can cause urinary discoloration that could effectively unblind subjects, participants on placebo received methylthioninium chloride (MTC) twice a week. MTC is primarily used as a dye and in the treatment of a hemoglobin condition. Researchers have also studied the molecule in the treatment of Alzheimer’s. TauRx picked an MTC dose for its LUCIDITY trial that it expected to have no effect on the disease but was surprised by the data. Read on Fierce Biotech >>
FDA nixes EUA ambitions for Eiger’s COVID treatment, proposes full approval pathway instead
October 5, 2022 / Eiger BioPharmaceuticals / COVID-19 / FDA / Prozac –The company says that following its Sept. 6 release, in which it said it was “not yet able to determine” whether or not it would meet EAU criteria, Eiger requested a pre-EUA meeting with the FDA. The company also submitted additional “morbidity and mortality outcomes data” from the investigator-sponsored Together trial it was relying on. In response, the FDA said thanks, but no thanks, denying the meeting request due to the “conduct” of the trial. The trial aims to asses already approved or under-development therapies as COVID-19 treatments, including OCD treatment fluvoxamine, Prozac and Tarpeyo. The primary endpoints were the change in emergency care, hospitalization and death compared to placebo. Read on Fierce Biotech >>
FDA Expands Patient Input on Drug Development
September 29, 2022 / FDA / Drug Development / Patient –Ten years ago, FDA launched an initiative to expand the role of patients in informing regulators and sponsors on most harmful effects of a disease and primary goals of treatment that can lead to desirable medical approaches. To further advance and refine the process, the agency is highlighting how the patient-focused drug development (PFDD) program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines. Read on Pharma Exec >>
PDS Biotech Announces Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial of PDS0101 in Combination With KEYTRUDA
October 3, 2022 / PDS Biotech / FDA / Drug Development – PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the treatment of unresectable, recurrent/metastatic human papilloma virus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC). “We are very pleased with the guidance received from FDA on key elements of the clinical program that will support the submission of a Biologics License Application (BLA) for our lead asset PDS0101,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule. This, along with the recent capital raise, allows us to efficiently advance our clinical programs.” Read on Yahoo Finance >>
Pfizer Completes Acquisition of Biohaven Pharmaceuticals
October 3, 2022 / Pfizer / Biohaven Pharmaceuticals – Pfizer Inc. (NYSE: PFE) announced today the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC® ODT (rimegepant), an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults.

The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including: Rimegepant, Zavegepant, and a portfolio of pre-clinical CGRP assets Read on Pfizer >>

// Research & Development

After $100M deal, J&J links gene therapy to improved vision in early-phase trial October 3, 2022 / Johnson & Johnson / MeiraGTx / Cell & Gene Therapy – J&J secured worldwide rights to the X-linked retinitis pigmentosa (XLRP) candidate and other prospects from MeiraGTx in 2019 in return for $100 million upfront and the promise of more on the back end. J&J and MeiraGTx moved the XLRP asset, botaretigene sparoparvovec, into a phase 3 clinical trial last year while still working to wrap up the expansion cohort of the earlier-stage study. The phase 1/2 clinical trial was primarily designed to assess the safety and tolerability of subretinal administration of the gene therapy. On that front, the expansion arm, details of which were shared at the American Academy of Ophthalmology 2022 annual meeting, offered some encouragement. Read Full Article on Fierce Biotech >>
Chasing Biogen and Sage, Eliem hustles depression drug into phase 2 after clearing up PK question October 5, 2022 / Eliem herapeutics / Biogen / Sage Therapeutics / Antidepressant – Like zuranolone, Eliem’s ETX-155 is a GABAA receptor positive allosteric modulator that is designed to treat conditions including major depressive (MDD) order. While Eliem has ceded a big head start to Biogen and Sage’s candidate, it is betting that its prospect’s apparent lack of a clinically meaningful food effect and longer half-life will translate into improved efficacy, tolerability, compliance and durability. Eliem is now preparing for the most rigorous test of its hypothesis yet. In the first quarter of next year, the biotech will start a phase 2a trial of either a 60 mg or 75 mg dose of ETX-155 in MDD. Eliem will decide the dose after assessing the effect of repeat 75 mg doses on healthy volunteers in a phase 1 trial. Read Full Article on Fierce Biotech >>
Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win
October 5, 2022 / Novo Nordisk / Insulin / Basal Insulin – Icodec already notched notable wins across its six-part Onwards phase 3 program, with parts 1, 2, 3, 4 and 6 all hitting their primary endpoints. The clinical successes raised hopes that insulin icodec will be able to address some of the issues associated with the use of once-daily basal insulin analogs such as Novo’s own Tresiba. In theory, reducing the frequency of dosing could improve convenience, adherence, quality of life and by extension, glycemic control. On Monday, the company completed the lineup, with Onwards 5, true to form, also hitting its primary endpoint. Icodec demonstrated non-inferiority in reducing hemoglobin A1c, a measure of blood sugar, in patients with type 2 diabetes at week 52 when compared with once-daily basal insulin analogs. Specifically, participants who received Icodec saw an HbA1c reduction of 1.68% points, compared with 1.31% for patients who received once-daily basal insulins. Read Full Article on Fierce Biotech >>
Pfizer pulls trigger on Voyager gene therapy capsid deal, clearing it to fire TRACER at CNS disease
October 4, 2022 / Voyager Therapeutics / Pfizer / Capsids / Cell & Gene Therapy – Voyager granted Pfizer an option on capsids for use in the treatment of neurologic and cardiovascular diseases one year ago, securing $30 million upfront and early external validation of its decision to pivot to its TRACER capsid discovery platform. The agreement featured a research term that extended to Oct. 1, 2022, during which Pfizer could evaluate the capsids before deciding whether to exercise its options. In the end, Pfizer exercised its option to use the capsid against a neurologic disease but turned down the chance to advance a cardiovascular program based on Voyager’s technology. The split decision means Voyager will receive $10 million upfront and potentially up to $290 million in milestones but miss out on the up to $300 million in paydays tied to the cardiovascular program. Read Full Article on Fierce Biotech >>
After years of manufacturing woes, Takeda is calling it quits on Natpara
October 4, 2022 / Takeda / Shire / Natpara / Rare Diseases – The Japan-based pharma has elected to nix all manufacturing of its Natpara injection for hypoparathyroidism in the U.S. and abroad by the end of 2024, a decision it credited to “unresolved supply issues that are specific to the product.” In the wake of that manufacturing halt, Takeda says it won’t put Natpara back on the market in the states or make the drug anywhere else globally. Natpara, known generically as parathyroid hormone, is marketed under the Natpar brand internationally. Takeda acquired the rare disease med in its $62 billion buyout of Shire. Read Full Article on Fierce Pharma >>
New drug could be ‘gamechanger’ for chronic cough sufferers
October 5, 2022 / New Drug / Chronic Cough – Prof Surinder Birring, a leading lung doctor, has led a global trial that found Gefapixant reduces a person’s coughing by up to 60% and brings some relief to 70% of those who take it. Birring, a professor of respiratory medicine at King’s College hospital in London, said that if it gained approval the experimental drug would be the first new treatment for more than 50 years to alleviate the symptoms of the debilitating condition. Read Full Article on The Guardian >>
Earlier Menopause is Associated With Higher Risk of Incident Frailty in Community-Dwelling Older Women in England
October 7, 2022 / Women’s Health / Menopause – Frailty is a medical condition of vulnerability to poor resolution of homeostasis after a stressor event and age-related decline in many physiological systems. Frail older adults are predisposed to adverse health outcomes, including falls, fractures, disabilities, hospitalization, and nursing home placement, and have substantially high mortality risk. Previous studies have consistently shown that women are frailer than men in all age groups and in different populations. Read Full Article on Medscape >>

// Politics

Federal government makes $53 million bet on low-cost medicine production in Virginia
October 4, 2022 / low-cost medicine production / Virginia – The facility they toured will be just one beneficiary of the $53 million grant, and a flood of local and state support that’s come along with it. The money will support Virginia’s Advanced Pharmaceutical Manufacturing cluster, a web of companies and research institutions stretching from Richmond to Petersburg. Virginia Senator Mark Warner said the investment in pharmaceuticals was a matter of national security. “We are in an economic competition with China unlike anything we’ve seen, ever,” he said, pointing to the precarity of drug supplies during the COVID-19 pandemic. “It’s not often that Uncle Sam comes up with $53 million.” Read Full Article on abc 8 news >>
Vir Biotechnology Awarded U.S. Government Contract to Support Pandemic Preparedness
October 4, 2022 / Vir Biotechnology / Pandemic – As part of BARDA’s ongoing effort to prepare and respond to public health emergencies, the agency will invest approximately $55 million initially for the ongoing and rapid development of VIR-2482, an investigational prophylactic monoclonal antibody (mAb) designed to protect against seasonal and pandemic influenza. This includes a Phase 2 pre-exposure prophylaxis trial expected to begin in the second half of 2022 with initial data anticipated in mid-2023. The balance of the award is subject to BARDA exercising up to 12 options in further support of the development of pre-exposure prophylactic antibodies including and beyond VIR-2482 for the prevention of influenza illness or possibly supporting medical countermeasures for other pathogens of pandemic potential. Read Full Article on El Paso Inc. >>
Drug companies in opioid crisis donated $27,000 to Ohio Rep. Tim Ryan
October 5, 2022 / Opioid Crisis / Drug Companies – Democratic U.S. Rep. Tim Ryan, who has made his opponent’s questionable record fighting the opioid epidemic a central theme of his campaign for Ohio’s open U.S. Senate seat, has received campaign donations over the years from drug distributors blamed for key roles in the crisis, an Associated Press review found. Read Full Article on CNBC >>