// Biotech and Pharma Therapeutics

Lilly, seeking better CNS gene therapies, pays $55M to join AbbVie on AAV specialist’s list of partners
January 4, 2023 / Emerging / Biopharma / Eli Lilly / Capsids / Biotherapeutics – Eli Lilly has once again moved to bolster its gene therapy capabilities, committing $55 million upfront and $685 million in milestones to access Capsida Biotherapeutics’ adeno-associated virus (AAV) engineering platform. Lilly has struck a pair of gene therapy buyouts in recent years, snapping up Prevail Therapeutics in 2020 in a $1 billion deal and paying $487 million upfront for Akouos last year. The latest agreement adds to the capabilities of Prevail, a biotech focused on AAV9 gene therapies for the treatment of genetically defined neurodegenerative diseases. Read Full Article on Fierce Biotech >>
Merck KGaA hands over IL-12-targeting cancer med to PDS Biotech in $121M deal
January 3, 2023 / Merck KGaA / PDS Biotechnology / National Cancer Institute / Immunotherapy – Merck KGaA’s new R&D strategy is continuing to run apace, with the company ramping up efforts to more swiftly sign onto and offload assets that have commercial potential. That plan has continued in the New Year, naturally, with the German Big Pharma handing over the rights of its IL-12-targeting cancer med to PDS Biotech in a deal worth more than $120 million. In exchange for M9241, PDS is paying $5 million upfront with $116 million waiting in the wings in potential biobucks, with the bulk of the milestone payments contingent on commercial achievements, according to Tuesday’s unveiling.Read Full Article on Fierce Biotech >>
Moderna sprints toward RSV podium behind GSK, Pfizer, with eyes on combo vax
January 4, 2023 / Moderna / Pfizer / GSK / RSV – The race to nab the first FDA approval of an RSV vaccine is largely a two-horse sprint between Pfizer and GSK. But, in an interview with Fierce Biotech Tuesday, Moderna CEO Stéphane Bancel maintained confidence that his company’s shot would stand out even as the development process lags months behind. Read Full Article on Fierce Biotech >>
Pear Therapeutics and Spero Health to Expand Access to Prescription Digital Therapeutics for People in Recovery Across Multiple Locations and States
January 4, 2023 / Spero Health / Opiod / FDA / Pear Therapeutics – Pear Therapeutics Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced the expansion of its collaboration with Spero Health, an integrated healthcare services organization specializing in local and affordable outpatient care for individuals suffering from substance use disorders, to provide adults suffering from substance use disorder (SUD) and opioid use disorder (OUD) access to reSET® and reSET-O®, for each respective condition. Spero Health, which has implemented reSET and reSET-O at 14 locations in Kentucky, intends to expand access to eligible patients at its 99 locations throughout Indiana, Kentucky, Ohio, Tennessee, West Virginia, and Virginia. The expansion is part of Spero Health’s commitment to increase patient engagement and retention in recovery by offering FDA-authorized innovative treatment options. Read Full Article on Biospace >>
BrainStorm Preps for Type A NurOwn Meeting, Shakes Up C-Suite
January 4, 2023 / Brainstorm / NurOwn / FDA – BrainStorm Cell Therapeutics concluded 2022 on a cautiously optimistic note as the FDA granted a Type A meeting to discuss the refuse to file letter it served the Israel and New York-based biotech in November for its ALS hopeful, NurOwn. The meeting is scheduled to take place on Jan. 11th. Read Full Article on Biospace >>

// 4th Industrial Revolution

Groundbreaking AI tool delivers real-time diagnoses during surgery
January 2, 2023 / AI / Surgery – When a patient undergoes a surgical operation to remove a tumor or treat a disease, the course of surgery is often not predetermined. To decide how much tissue needs to be removed, surgeons must know more about the condition they are treating, including a tumor’s margins, its stage and whether a lesion is malignant or benign— determinations that often hinge upon collecting, analyzing, and diagnosing a disease while the patient is on the operating table. Read Full Article on The Bright Side of News >>
AI Can Now Help Your Smartphone Take Your Blood Pressure
January 4, 2023 / AI / Smart Phone / Blood Pressure – For some time now, smartphone apps have been used to measure blood pressure; this type of contactless blood pressure tracking has been something of a Holy Grail for cardiologists and the tech industry. But the technique most mobile devices rely on, photoplethysmography (PPG), has its limitations: using a camera to detect changes in light reflected off of skin to gauge blood flow has accuracy issues. To get better results, researchers at the University of South Australia (UniSA) and Baghdad’s Middle Technical University turned to AI. They designed a no-contact blood pressure measuring system which they say is about 90% as accurate as a digital sphygmomanometer. Full Article on Health Tech Insider >>
India launches incentive scheme to boost digital health record adoption
January 4, 2023 / India / Digital Health / Adoption – India’s National Health Authority is providing incentives to healthcare providers and other stakeholders of the country’s digital health ecosystem who are promoting the creation of digital health records. Up to Rs 40 million (nearly $500,000) will be made available to 10 or more-bed health facilities, diagnostic centres, and providers of digital solutions, such as HMIS and LMIS. It will be provided based on the number of digital health records created and linked to the Ayushman Bharat Health Account. Read Full Article on Healthcare IT News >>
Mercy Virtual Care Center: A deep dive into a virtual hospital
January 3, 2023 / Mercy Virtual Care Center / Virtual Hospital – “In our ambulatory virtual programs, we manage complex chronically ill patients,” said Annie Bannister, RN, executive director of vEngagement at Mercy. “We follow these patients longitudinally, meaning when someone enrolls with us, we will manage them alongside their primary care physician and specialists throughout their entire care journey. Read Full Article on Healthcare IT News >>
Deep-Learning Model Can Detect Disease-Causing Mosaic Mutations
January 3, 2023 / Deep-leaning model / DNA Mutations / Mosaic Mutations / California – Despite the wide range of capabilities of current DNA mutation software detectors, most cannot perceive mosaic mutations, that is, DNA mutations in a small percentage of cells, existing within normal DNA sequences, according to a press release. In addition, medical geneticists reviewing DNA sequences by eye can be time-consuming and may lead to error. Read Full Article on Health IT Analytics >>

// Business & Markets

Roche further taps drug discovery spinout’s Nimble tech in $1.1B biobucks deal
January 5, 2023 / Nimble Therapeutics / Genetech / Roche / Emerging Biopharma – Roche is making sure its peptide discovery spinout Nimble Therapeutics stays close with a revision of the companies’ development partnership valued at up to $1.1 billion. The pharma’s Genentech unit will pay out $20 million to Nimble upfront in the revamped collaboration, with up to $1.1 billion possible in near-term, preclinical, clinical, and commercial milestone payments, plus royalties. Read Full Article on Fierce Biotech >>
Hunting for cash, Jounce sells remaining stake in tumor antibody to partner Gilead for $67M 
January 3, 2023 / Gliead Sciences / Jouce Therapeutics / Licensing Deals / Solid Tumor – While the tough funding environment has forced many biotechs to lay off staff or pare back their pipelines, Jounce has at least found a way to make some easy money in the process. The biotech has sold its remaining stake in an anti-CCR8 antibody dubbed GS-1811 to Gilead for $67 million. Read Full Article on Fierce Biotech >>
First startup blooms from Mayo Clinic cell and gene therapy accelerator with $750M Cellectis partnership
January 3, 2023 / Primera Therapeutics / Cellectis / Mayo Clinic / Mitochondrial Diseases – Seeds from Mayo Clinic’s cell and gene therapy accelerator Mayflower Bioventures have taken flight in a new biotech called Primera Therapeutics, which launches today with a blossoming $750 million partnership to work on therapies for mitochondrial diseases. Read Full Article on Fierce Biotech >>
AmerisourceBergen Completes Acquisition of PharmaLex
Jaunary 3, 2023 / AmerisourceBergen / PharmaLex – The acquisition of PharmaLex enhances AmerisourceBergen’s growth strategy by advancing its leadership in specialty services and global platform of pharma manufacturer services capabilities. PharmaLex’s regulatory affairs, development consulting and scientific affairs, pharmacovigilance, and quality management and compliance services expand AmerisourceBergen’s role as partner of choice for biopharmaceutical partners across the pharmaceutical development and commercialization journey. Read Full Article on Biospace >>
Belharra Therapeutics Debuts With $130 Million in Funding
January 4, 2023 / Belharra Therapeutics / Debuts / chemoproteomics – Belharra Therapeutics, Inc. today emerged from stealth mode with a novel photoaffinity-based chemoproteomics platform capable of identifying non-covalent, small molecule drug candidates for any protein. The company has secured $130 million in capital, including $50 million in Series A financing from founding investor Versant Ventures and a multi-year collaboration with Genentech, a member of the Roche Group, that will provide $80 million in upfront capital, also announced today. Belharra is the most recent company to emerge from Versant’s Inception Discovery Engine. Read Full Article on Biospace >>

// Legal & Regulatory

Burned by FDA rejection, Y-mAbs drops 3rd of staff, cancer vaccine ambitions
January 5, 2023 / Y-mAbs Therapeutics / Layoffs / Cancer Vaccine / FDA Advisory Committee – In the wake of a bruising FDA rejection for its rare pediatric cancer drug, Y-mAbs Therapeutics has followed the increasingly common biotech trend of laying off staff and trimming back its remaining pipeline. The company had a rough end to the year, with an FDA advisory committee delivering a damning 0-16 verdict on approving omburtamab to treat central nervous system/leptomeningeal metastases in children with neuroblastoma. Panel members expressed skepticism of whether the single arm study had proven the therapy’s effectiveness, with the FDA rejecting the application in December. Read Full Article on Fierce Biotech >>
AstraZeneca, Sanofi tee up 3-way RSV battle in 2023 as FDA signals expedited review for antibody
January 5, 2023 / RSV / AstraZeneca / Sanofi / U.S. FDA – Thanks to the FDA’s expedited reviews, an RSV prevention market battle between several pharma giants may kick off in 2023. AstraZeneca and Sanofi will learn about the FDA’s verdict for their RSV antibody drug nirsevimab in the third quarter of 2023, the companies said Thursday. European regulators already cleared the RSV preventative therapy under the brand name Beyfortus in early November. Read Full Article on Fierce Biotech >>
Jazz sues generics makers for infringement on cannabis-derived epilepsy drug
January 5, 2023 / Jazz Pharmaceuticals / Generics / Epidiolex / Patent Infringement – Pharma companies routinely sue generics makers for alleged patent infringement with their proposed copycats. But the fight over Jazz Pharmaceuticals’ Epidiolex marks a more unique fight against pending generic competition. Jazz is suing Teva, Apotex, Alkem and a few other generic drugmakers for alleged infringement on the cannabis-derived therapy, the company said in a Securities and Exchange Commission filing. The drug won its FDA approval back in 2018 as the first therapy comprised of an active ingredient derived from marijuana. Read on Fierce Pharma >>
Pfizer wins—again—in courtroom fight versus Astellas over Lexiscan patents
January 4, 2023 / Pfizer / Astellas / Hopira / Patent Infringement – It’s near the end of the game and Astellas is running out of timeouts as it tries to stave off generic competition for its scanning agent Lexiscan. Last week, the Court of Appeals for the Federal Circuit (CAFC) upheld a Delaware district court ruling that Pfizer’s Hospira did not infringe on patents in developing its generic version of the drug, Astellas said in a release on Wednesday. Read on Fierce Pharma >>
Novartis pays $245M to settle Exforge generic pay-for-delay lawsuit
January 3, 2023 / Novartis / Endo / Par Pharmaceutical / Lawsuits –Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements. The Swiss pharma will pay altogether $245 million in separate settlements with direct purchasers, indirect purchases and retailers who had accused the company of colluding with Endo’s Par Pharmaceutical to push back the launch of a generic version of Novartis’ high blood pressure med Exforge. A Novartis spokesperson confirmed the agreement with Fierce Pharma.Read on Fierce Pharma >>

// Research & Development

Lilly, Merck double down on peptide-targeted drug delivery, betting billions in biobucks on PeptiDream pacts
January 3, 2023 / Eli Lilly / Merck & Co. / PeptiDream / Targeted Therapies – Eli Lilly and Merck & Co. have identified PeptiDream’s peptides as a way to deliver therapeutic payloads to targets, leading them both to lay down more than $1 billion in milestones to work with the biotech. PeptiDream is a Japanese biotech that has landed a string of deals with drug developers such as Alnylam and Takeda on the strength of its peptide discovery platform system. The system enables PeptiDream to identify peptides that can serve as the targeting mechanism for therapies. Once conjugated, the peptides take payloads to their targets to potentially deliver a potent hit without intolerable toxicity. Read Full Article on Fierce Pharma >>
Renibus’ cardiac surgery drug aces phase 2 trial as biotech adds extra CEO
January 5, 2023 / Renibus Therapeutics / Emergining Biopharma / Chutes and Ladders – Renibus Therapeutics’ lead candidate for patients undergoing cardiac surgery has sailed through a phase 2 trial, setting up the Texan biotech for a late-stage study in the coming months as it also unveiled a double-dose of CEOs. The therapy, dubbed RBT-1, is a novel stannous protoporphyrin and iron sucrose fixed-combination agent designed to induce the upregulation of biomarkers of cytoprotective preconditioning. The aim is to prevent complications that arise after cardiothoracic surgery. Read Full Article on Fierce Biotech >>
Takeda troops rare disease drug to regulators after glimpse at phase 3 data
January 5, 2023 / Takeda / Rare Diseases / Clinical Trial Data / Enzyme Disorders – Takeda has pressed go on plans to seek approval for its enzyme replacement therapy in an ultra-rare disease. Citing the “totality of the evidence” seen in phase 3, the Japanese drugmaker outlined its intent to head to regulators armed with data on the ADAMTS13 replacement therapy it acquired from Shire. Read Full Article on Fierce Biotech >>
Vera finally notches a win for Merck KGaA castoff in autoimmune kidney disease
January 3, 2023 / Vera Therapeutics / Merck KGaA / Autoimmune Disease – Merck KGaA eventually abandoned atacicept after trying again and again in multiple autoimmune disorders. Now, Vera Therapeutics has succeeded where the Big Pharma failed. Vera announced Tuesday after market that atacicept reduced a biomarker linked to improved kidney function in patients with a severe autoimmune disease during a midstage trial, setting up advancement to a phase 3 study.is standing by its therapy, saying the trial still demonstrates “clear evidence of effect.” Read Full Article on Fierce Biotech >>
Particulates, label issues prompt separate recalls for Pfizer’s Hospira and Accord
January 4, 2023 / Accord / Hospira / Pfizer / Product Recall – Right before the New Year, Pfizer’s Hospira and Accord initiated a pair of drug recalls for separate reasons. Hospira, which is owned by Pfizer, recalled one lot of its vancomycin hydrochloride injection vials at the 1.5-gram dose because of glass particles in the vials. Accord, for its part, pulled a lot of 500-mg daptomycin after receiving a complaint from a hospital pharmacy about mislabeled cartons. Read Full Article on Fierce Pharma >>

// Politics

Amgen garners wide support from pharma peers in Supreme Court patent fight with Sanofi
January 4, 2023 / Amgen / Sanofi / Patent Lawsuits / PCSK9 – In a closely watched patent dispute playing out at the U.S. Supreme Court, Amgen has drummed up support from fellow drugmakers large and small, plus industry associations and intellectual property groups. As part of Amgen’s case against Sanofi centered on the two companies’ PCSK9 cholesterol drugs, several biopharma companies including AbbVie, Bristol Myers Squibb and GSK, as well as organizations like the National Association of Patent Practitioners and the Intellectual Property Professors, have thrown their support behind Amgen’s appeal in separate briefs filed to the U.S. high court. Read Full Article on Fierce Pharma >>
Mitch McConnell. ‘Big Pharma,’ the Metric System
January 2, 2023 / Mitch McConnell / Big Pharma – Xi Jinping, the boss of the CCP, says that his state is on “the right side of history.” I begin my Impromptus today by addressing this issue. There are plenty of other issues as the column proceeds. You want issues? I got issues. The column ends with some memories of Bill Buckley, particularly on New Year’s Eve. Read Full Article on National Review >>
Pfizer political contributions filled state campaign coffers through the COVID-19 pandemic
January 2, 2023 / Pfizer / State Campaign / COVID-19 – Alabama politicians took money from the largest and most prolific vaccine manufacturer through the COVID-19 pandemic. Pfizer is the manufacturer of the most prolific version of the COVID-19 vaccine and the first to receive first full approval from the Food and Drug Administration (FDA). With the polarizing effects of COVID and the vaccine in political discourse, people have long expressed concern about pharmaceutical companies’ influence on politicians. Read Full Article on 1819 News >>
Pharma execs see inflation as the No. 1 challenge in 2023: survey
January 5, 2023 / Global Data / Teva Pharmaceuticals / Inflation Reduction Act – Heading into 2023, inflation is the top concern for the pharmaceutical industry, according to a poll of executives conducted by GlobalData Healthcare. The survey, which was taken between Oct. 26 and Nov. 23, showed that executives placed inflation first, drug pricing and reimbursement constraints second, the Ukraine conflict third, and the political divide in the United States fourth among the top challenges hampering growth in the industry. Read Full Article on Fierce Pharma>>
Health care lobbyists are bracing for Chair Bernie Sanders
January 3, 2023 / Healthcare / Chair Bernie Sanders / Vermont – Health care lobbyists representing insurers, drugmakers and a range of powerful industry interests are steeling themselves for a Senate chair immune to their usual charms — Bernie Sanders. The Vermont independent is set to take over the Senate’s Health, Education, Labor and Pensions Committee next month. Leading the panel gives the Medicare-for-All proponent oversight authority over some of his policy priorities — drug pricing, workers’ rights and income inequality, and student and medical debt.Read Full Article on MSN >>