// 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.
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.
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.”
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,”.
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.
// 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.
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.
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.
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).
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.