// Biotech and Pharma Therapeutics

Pfizer snaps up rights to RSV therapy left behind in ReViral buy for $20M
 December 19, 2022 / Pfizer / RSV / LianBio / Licensing Deals – Pfizer, looking to be the king in respiratory syncytial virus vaccines and therapeutics, is going back to scoop up one therapy that was left on the table earlier this summer when the pharma giant acquired ReViral and its RSV portfolio. The Big Pharma is paying $20 million cash to LianBio for the rights to develop and commercialize sisunatovir in Greater China. LianBio licensed the rights to the therapeutic from ReViral in 2021, meaning it was not a part of Pfizer’s earlier deal. Read Full Article on Fierce Biotech >>
Septerna Announces the Formation of a Cross-Functional Scientific and Drug Discovery Advisory Board
 December 19, 2022 / Septerna / Drug Discovery / Technology Advisors – Septerna, Inc., a biotechnology company discovering and advancing novel small molecule medicines targeting G protein-coupled receptors (GPCRs), today announced the establishment of its cross-functional scientific and drug discovery advisory board with seasoned industry drug hunters and leading academic GPCR biology and pharmacology scientists. Read Full Article on Biospace >>
UCHealth slashes code blues up to 70% with telehealth technologies
 December 20, 2022 / UCHealth / Telehealth / Virtual Deterioration –The organization had a new use case for virtual care, a program called Virtual Deterioration. Essentially, it was trying to find patients who were deteriorating in the hospital sooner in order to provide rescue and treatment faster to give them the best outcome.

“What we were seeing prior to this program was a lot of variability as we tried to detect deterioration, and then once we were detecting it, reaching out to the bedside caregivers as to what happened next,” said Dr. Diana Breyer, chief medical officer of the Northern Region at UCHealth.Read Full Article on Healthcare IT News >>

Bluebird’s adolescent sickle cell ambitions are back in flight after yearlong partial hold lifted
 December 19, 2022 / Bluebird Bio / FDA / Sickle Cell Disease / Cell & Gene Therapy –The FDA has placed a nugget of positive clinical news into bluebird bio’s stocking, lifting a year-old partial clinical hold of its sickle cell gene therapy for patients under 18. The regulatory wave-through, announced Monday, follows an investigation into a case of anemia among one of the patients treated with lovo-cel, spurring a hold on the trial in December 2021. The company’s assessment, which also included a similar case in the adult trial, found that the two cases were linked to a specific gene mutation. As a result, the company added the genotype to its inclusion criteria. Read Full Article on Fierce Biotech >>
Otonomy shuts up shop, lays off all employees after string of ear drug failures
 December 20, 2022 / Otonomy / Layoffs / Hearing Loss / Job Cuts –You have to admire Otonomy’s perseverance. The biotech has experienced a series of clinical failures throughout a grueling year but kept the faith in its ear disorder pipeline. But a phase 2 failure of its hearing loss drug OTO-413 in October may have proved the final nail in the coffin. The company confirmed yesterday that it will be winding down operations and revealed that all remaining employees had already been laid off Dec. 15. Read Full Article on Fierce Biotech >>

// 4th Industrial Revolution

How Bluetooth Technology Is Bolstering the New Era of Hearing Accessibility
December 20, 2022 / Bluetooth / Hearing Accessibility / FDA / Hearing Aids –In August, the Food and Drug Administration established a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. The move intends to help make hearing aids more accessible and affordable for some of the 30 million U.S. adults currently experiencing hearing loss. Historically, confusion, stigma and lack of access have prevented most people (especially older Americans and those living in rural areas) from addressing their hearing health. As we anticipate the rollout of OTC hearing aids, the role of Bluetooth audio is pivotal. Read Full Article on Hit Consultant >>
PAVmed Partners with Novosound on Ultrasound Imaging Technology
December 22, 2022 / PAVmed / Novosound / Medical Device –“Nearly all of the advances in ultrasound imaging technology over the past several decades have focused on leveraging an explosion of computational power for digital image processing, along with novel configurations of otherwise decades-old, rigid, machined ceramic, piezoelectric sensors,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “The Novosound team has developed groundbreaking technology whereby the piezoelectric material is lithographically ‘printed’ on a flexible thin-film substrate and have proven the technology’s applicability in a commercially successful industrial application.” Full Article on Biospace >>
Health Tech Innovation: How to Advance Data Security To Support Healthcare Accessibility
December 20, 2022 / Health Tech / New Tech / Healthcare / Healthcare Security –In the U.S. in July of this year, there were 66 data breaches of 500 or more exposed records reported to the Department of Health and Human Services’ Office for Civil Rights. While the number of breaches was down slightly from June, the overall number is still above the monthly average of 57 for 2022. One reason for this surge in attack activity is that digital transformation has outpaced current security controls in healthcare, creating holes for bad actors to exploit. The explosive growth of the interconnected internet of things (IoT) and modern medical devices designed to improve patient care has also expanded attack surfaces – and cybercriminals are taking advantage. Read Full Article on MedCity News >>
RTM Reimbursement Represents a New Age for Digital Therapeutics
December 21, 2022 / Digital Therapeutics / Medicare / Medicaid Services – In 2022, Centers for Medicare and Medicaid Services (CMS) introduced five new CPT codes for Remote Therapeutic Monitoring (RTM), marking the entry of patient-reported, non-physiological data into coverage criteria. For 2023, CMS plans to further expand coverage to include a CPT code for cognitive behavioral therapy monitoring. The advent of RTM reimbursement marks an important milestone in the budding digital therapeutics space, due primarily to the following reasons: Read Full Article on MedCity News >>
Telehealth company MediOrbis integrates Kahun’s AI-based digital intake tool
December 21, 2022 / MediOrbis / Kahun / AI / Healthcare – Telehealth company MediOrbis announced a partnership with Kahun, which offers an AI-enabled digital intake tool that conducts clinical assessments via a chatbot and provides recommendations for further evaluation. MediOrbis, an Ohio-based multi-specialty telehealth company, offers chronic disease management and remote patient monitoring services, a medical weight loss program, virtual primary care, integrated specialty care and on-demand urgent care.Read Full Article on Mobihealth News >>

// Business & Markets

Lilly doubles down on ProQR’s RNA tech in $75M deal expansion, spurring biotech’s much-needed share rally
December 22, 2022 / Eli Lilly / ProQR Therapeutics / Licensing Deals / Cell & Gene Therapy – RNA expert ProQR Therapeutics is ending a tough year on a high note thanks to a $75 million expansion of a genetic medicines partnership with Eli Lilly. This expansion should be good news for the Dutch biotech, which cut 30% of its staff in the spring after a phase 2/3 med called sepofarsen failed. In August, ProQR said it would seek partnerships for its ophthalmology programs. The company refocused on its RNA-editing technology and wound down clinical trials for other candidates to preserve cash in the meantime. Read Full Article on Fierce Biotech >>
Merck Expands ADC Footprint with $9.3B Kelun Licensing Deal
December 22, 2022 / Merck / Kelun / Licensing Deal / Investing –Thursday, Merck entered into a license and collaboration agreement with Chinese company Kelun-Biotech to develop seven antibody-drug conjugates (ADC) candidates against oncology targets. Under the terms of the deal, Merck will pay $175 million for future exclusive rights to research, develop, manufacture and commercialize the preclinical ADC therapeutics, as well as for the option to license additional ADC candidates. Read Full Article on Biospace >>
Vistagen buys out Pherin more than 4 years after licensing now-lead social anxiety spray
December 21, 2022 / VistaGen Therapeutics / Emerging Biopharma / M&A / Anxiety – Vistagen is doubling back to a familiar face, acquiring Pherin Pharmaceuticals in a bid to wipe out any future royalty payments in addition to nabbing three new assets. The deal comes more than four years after Vistagen licensed Pherin’s nasal spray to treat social anxiety, which sits atop the former’s pipeline. The full amount of the deal was not disclosed in the announcement Wednesday, but Vistagen said it was handing over 12.4 million of its shares plus a “nominal amount of cash.” A spokesperson for the biotech didn’t immediately have an answer regarding the total price of the acquisition. Read Full Article on Fierce Biotech >>
Employee wellness platform Wellable acquires DailyEndorphin
December 22, 2022 / Wellable / DailyEndorphin / Wellness Platform / Corporate Wellness – Employee wellness company Wellable acquired DailyEndorphin, which offers corporate wellness challenges in which employees can set up group fitness or nutrition programs and invite their colleagues to participate. DailyEndorphin offers challenges for exercise, step count, nutrition, weight and hydration. Boston-based Wellable will add DailyEndorphins assets to its Wellable Wellness Platform, which also includes an incentive program and support model, a personal wellness assessment and clinical event verifications (where flu shots and preventative care are verified). The employee-focused company also has health content and on-demand classes. Read Full Article on MobiHealth News>>
Pfizer gives ORIC shares big boost with multiple myeloma collab, $25M investment
December 22, 2022 / Pfizer / ORIC Pharma / Multiple Myeloma / Equity Investment – ORIC Pharmaceuticals now has enough cash to run operations through the first half of 2025 thanks to a $25 million equity investment and a new clinical partnership with Pfizer. The pharma giant will work with the therapeutic resistance-focused biotech on ORIC-533, an oral small molecule inhibitor of CD73 in phase 2 development for multiple myeloma, according to a Thursday press release. Read Full Article on Fierce Biotech>>

// Legal & Regulatory

Ferring wins FDA approval for bladder cancer gene therapy
December 19, 2022 / FDA / Ferring / Bladder Cancer / Gene Therapy / FerGene – Also known as nadofaragene firadenovec, Adstiladrin has been in development since 2011, originating at a research institute in Finland. Its original owner, FKD Therapies Oy, licensed the treatment to Ferring in 2018. One year later, Ferring partnered with Blackstone Life Sciences to invest $570 million in development of the therapy for high-risk BCG-unresponsive NMIBC. At the time, the two companies set up a subsidiary called FerGene to commercialize the drug in the U.S. Read Full Article on Biopharma Dive >>
In new lawsuit, J&J’s talc subsidiary takes issue with expert witness testimony
December 20, 2022 / Johnson & Johnson / Lawsuit – In the latest twist, J&J is taking issue with testimony from an expert witness used by some plaintiffs. In a lawsuit, J&J’s bankrupt subsidiary, LTL Management, accused the witness of falsifying information used in hundreds of talc cases. In the filing, dated Dec. 16, J&J’s subsidiary accuses Dr. Jacqueline Moline of “knowing and repeated disparagement” of J&J’s baby powder and shower gel. The company’s attorneys cited a 2019 article published by Dr. Moline in which she claimed that 33 individuals who used talc powder and later developed the asbestos-related cancer mesothelioma had no other potential exposure to asbestos. Read on Fierce Pharma >>
New HIPAA rule from CMS would streamline transactions with attachments, e-signatures
December 19, 2022 / HIPAA / Electronic Signatures / Healthcare – The proposed rule is titled Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard (CMS-0053-P). If finalized, it would promote standards adoption for transactions with attachments for prior authorizations, including medical charts, X-rays and provider notes that document physician referrals. The modifications to HIPAA would also include a standard for the referral certification and authorization transaction. The proposed rule could save $454 million a year in administrative costs, according to CMS, and is another instance of the agency’s efforts to reduce paperwork burdens and streamline provider and patient experience. Read on Healthcare IT News >>
Pfizer, Sanofi settle first California Zantac case slated for trial: report
December 22, 2022 / Zantac / Pfizer / Sanofi / Settlement – Bloomberg first reported the news of the settlement, which comes after a U.S. District Judge ruled against the plaintiffs in the federal group of cases against the companies and others. Earlier this month, that ruling took out about 50,000 Zantac claims off the board. As for the California settlement, that lawsuit came in California Superior Court for Alameda County, Bloomberg reports. The financial terms of the agreement were not revealed, the news service said. Goetz also sued GSK, and that jury will start hearing evidence in February. Read on Fierce Pharma >>
After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca
December 22, 2022 / Gilead Sciences / HIV / Injectable – Gilead Sciences’ Sunlenca is now cleared to be used in adults whose HIV-1 infection is multi-drug resistant due to high levels of prior treatment. The drug is targeted at the many HIV-infected individuals who cannot achieve viral suppression—even with the range of treatments available. Viral suppression occurs when the virus is reduced to undetectable levels, which makes people unable to spread the virus, Jared Baeten, M.D., Ph.D., Gilead’s vice president of clinical development, explained in an interview with Fierce Pharma. Read on Fierce Pharma >>

// Research & Development


Eli Lilly Expands RNA Editing Collaboration with ProQR Therapeutics
December 22, 2022 / Eli Lilly / RNA Editing / ProQR / Axiomer –Thursday, shares of ProQR Therapeutics surged in premarket trading in response to an expanded RNA editing licensing agreement with Eli Lilly. The new agreement will reportedly center around the discovery and development of additional assets using ProQR’s Axiomer technology. Lilly and Netherlands-based ProQR initially entered into a five-target collaboration in 2021. The partnership harnesses ProQR’s proprietary Axiomer RNA editing platform to target disorders of the liver and nervous systems. Read Full Article on Biospace>>
Cancer center leaders lay bare CAR-T makers’ struggles—and an unexpected laggard
December 20, 2022 / CAR-T / Bristol Myers Squibb / Johnson & Johnson / Gilead Sciences – This year, the FDA moved two CAR-T therapies into earlier large B-cell lymphoma (LBCL) and cleared a second cell therapy for multiple myeloma. But despite five years of collective experience making and selling engineered human cell products, the biopharma industry is still struggling to ensure smooth and timely access. Cell therapy leaders at three top U.S. cancer hospitals—Memorial Sloan Kettering Cancer Center, Moffitt Cancer Center and City of Hope—are not satisfied with CAR-T availability and their manufacturers’ operations. During separate interviews at the recent American Society of Hematology annual meeting, the experts said manufacturing constraints were their top sticking point, especially for the myeloma CAR-Ts from Bristol Myers Squibb and Johnson & Johnson. Read Full Article on Fierce Pharma >>
Magenta halts high-dose group in leukemia trial after serious adverse events
December 20, 2022 / Magenta Therapeutics / Acute Myeloid Leukemia / Adverse Events – Magenta Therapeutics has stopped dosing a group of patients after a serious adverse event was reported in a phase 1/2 trial for the biotech’s leukemia med. MGTA-117 is being tested in the split-phase dose-escalation trial in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome. Magenta is assessing several doses including 0.13 mg/kg in cohort 4. After dosing three patients in this group, two experienced dose-limiting toxicities. Read Full Article on Fierce Biotech >>
Cerevel investors’ blood pressure relieved as safety data de-risks schizophrenia drug
December 20, 2022 / Cerevel Therapeutics / Pfizer / Schizophrenia / Emerging Biopharma – Cerevel Therapeutics investors themselves had some raised blood pressure as they anxiously awaited phase 1 safety results for the biotech’s schizophrenia drug. With the news that it does not, in fact, raise blood pressure, an analyst from Mizuho Securities is hoping the rest of the Pfizer apprentice’s pipeline can shine. Emraclidine was previously found to reduce symptoms of schizophrenia in a phase 1b clinical trial, setting up a move to phase 2 and a stock price boom for the biotech. But questions remained about safety, specifically, whether the therapy raised blood pressure in patients who require chronic dosing. Read Full Article on Fierce Biotech >>
AstraZeneca’s Forxiga recommended in EU for chronic heart failure
December 19, 2022 / Astra Zeneca / Forxiga / Cardiovascular – AstraZeneca’s Forxiga (dapagliflozin) has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency across the European Union (EU). It involves the treatment of heart failure with reduced ejection fraction and covers patients across the full spectrum of left ventricular ejection fraction (LVEF), including heart failure with mildly reduced and preserved ejection fraction. The positive opinion positive follows results from the DELIVER phase 3 trial – published in The New England Journal of Medicine – and data from a pre-specified, pooled analysis of the DAPA-HF and DELIVER phase 3 trials published in Nature Medicine. The study demonstrated that Forxiga was the first heart failure medication to provide mortality benefit across the entire ejection fraction range. Read Full Article on Pharma Times >>

// Politics

FDA’s accelerated approval reforms sneak into Congress’ last-minute spending bill
December 20, 2022 / FDA / Congress / Robert Califf / Accelerated Approval – When Robert Califf, M.D., retook the helm of the FDA earlier this year, reforming the accelerated approval pathway for new drugs was one of his top priorities. Fast forward almost a year and those reforms are close to being cemented into law after they slid through negotiations to make the latest draft of Congress’ annual spending bill, which was unveiled Tuesday morning. If passed, the bill would codify more power for the FDA, namely giving the agency the power to request that confirmatory trials are initiated before a company receives accelerated approval. Once a company does receive an accelerated approval, it will be required to provide confirmatory trial status reports to the FDA every six months. Read Full Article on Fierce Biotech >>
25 Governors Pressure Biden Admin to End Public Health Emergency
December 21, 2022 / Joe Biden / Covid-19 / Medicaid / U.S. Governors –Nearly three years into the Covid-19 pandemic, 25 governors on Monday wrote a letter urging President Joe Biden to put an end to the public health emergency. The public health emergency is set to expire on January 11. However, the Biden administration has said that it will provide a 60-day notice before it decides to end the emergency. Since no warning was issued in November, it will likely be extended to April. Read Full Article on MedCity News >>
Bill could pave the way for prescription digital therapeutics reimbursement
December 20, 2022 / Bill / Digital Therapeutics / Healthcare / U.S. Senate-New legislation would allow for reimbursement of prescribed digital therapeutics under Medicare, which proponents argue could increase access to these emerging treatments. Still, others say it’s new technology, and the wrong reimbursement model could tamper innovation and increase patient costs. The Access to Prescription Digital Therapeutics Act of 2022, introduced in the U.S. Senate in March, aims to amend the Social Security Act to provide Medicare coverage and reimbursement for prescription digital therapeutics. Read Full Article on MobiHealth News >>
2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line
December 21, 2022 / U.S. FDA / Accelerated Approval / Year-ahead Forecast / Richard Pazdur –In what could represent a watershed moment in the FDA’s cancer drug practice, GSK pulled an accelerated approval for multiple myeloma drug Blenrep at the request of the FDA just 15 days after unveiling a confirmatory trial failure. The move reflected a broader makeover happening at the FDA’s oncology department, a GSK executive and an analyst said. An emphasis on accelerated approval guidelines as part of an “evolving regulatory environment in the U.S.” was the key driver behind GSK’s decision to pull Blenrep “in an expeditious fashion,” Hesham Abdullah, GSK’s global head of oncology development, said in a recent interview with Fierce Pharma. Read Full Article on Fierce Pharma >>