// Biotech and Pharma Therapeutics

AstraZeneca beefs up COPD pipeline with $400M biobuck bet on C4X program
November 28, 2022 / AstraZeneca / Chronic Obstructive Pulmonary Disease / Licensing Deals / Respiratory Diseases – AstraZeneca has moved to strengthen its respiratory disease pipeline, wagering $400 million in biobucks for the global rights to a preclinical C4X Discovery NRF2 activator program with applications in chronic obstructive pulmonary disease (COPD). Interest in targeting NRF2 to treat COPD and other diseases dates back more than a decade. Initially, the work focused on covalent modification of cysteine residues on KEAP1, which regulates NRF2, but poor selectivity and off-target toxicity led some groups to change tacks. Specifically, the groups sought to block the protein-protein interaction between KEAP1 and NRF2. Read Full Article on Fierce Biotech>>
AstraZeneca forges deeper into cell therapies with $200M takeover of solid tumor TCR biotech
November 29, 2022 / Neogene Therapeutics / AstraZeneca / T-cell Therapy / Cell & Gene Therapy – AstraZeneca is stepping up its pitch for a slice of the cell therapy space, paying $200 million upfront for a solid tumor player that recently hustled an autologous, fully individualized, multispecific prospect into the clinic. The biotech, Neogene Therapeutics, is part of a clutch of companies that see T-cell receptor therapies (TCR-Ts) as the key to expanding the modality into solid tumors. Using its neoantigen TCR discovery and T-cell engineering platform, Neogene aims to find neoantigens, plus TCRs that target them, for each patient and then create T cells with the neoantigen-specific TCRs. Read Full Article on Fierce Biotech >>
Bayer’s blockbuster hopeful Nubeqa debuts in later-stage prostate cancer in UK under early access program
November 28, 2022 / Bayer / Nubeqa / Prostate Cancer / Orion – Monday, Bayer said the U.K. is rolling out Nubeqa in tandem with androgen deprivation therapy (ADT) and the chemotherapy docetaxel “immediately,” following a speedy approval in metastatic hormone-sensitive prostate cancer (mHSPC) from the Medicines and Healthcare Products Regulatory Agency.The accelerated approval comes under the regulatory program called Project Orbis, an international team-up between drug regulators in countries like the U.K., the U.S. and Australia. It’s designed to hasten the approval process for promising cancer meds, NHS England explains. Read Full Article on Fierce Pharma >>
Bristol Myers has change of heart on cardiovascular gene therapy pact, terminating uniQure deal
November 29, 2022 / Bristol Myers Squibb / uniQure / Cell & Gene Therapy – Bristol Myers Squibb is breaking off its collaboration and license agreement with uniQure, calling time on a pact that was intended to deliver gene therapies against multiple cardiovascular disease targets. The original deal dates back to 2015, when Bristol Myers paid $50 million upfront to form a partnership that covered a gene therapy program for congestive heart failure. In 2019, Bristol Myers asked uniQure to extend the initial four-year research term by one year, only to be rebuffed by its partner. The two sides agreed to an amended deal in 2020. Read Full Article on Fierce Biotech >>
Persistent Lexicon still working to get an audience with FDA on Type 1 diabetes prospect
December 1, 2022 / Lexicon Pharmaceuticals / FDA / Sotagliflozin / Type 1 Diabetes – The Texas pharma—convinced of the value of its diabetes candidate sotagliflozin—has clapped back at its latest rejection from the FDA, asking to be heard in its attempt to gain approval for the drug in Type 1 diabetes. Sotagliflozin, which won approval in Europe for Type 1 diabetes in 2019, was first rejected in the U.S. that same year over safety concerns, prompting Sanofi to bail on a partnership deal with Lexicon. The money gained in that divorce has helped Lexicon continue its pursuit. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

Franciscan Health expands its Epic-linked telemedicine offerings
December 1, 2022 / Telemedicine / Telehealth Tech / Franciscan Health – In February 2020, some specialties were in the process of requesting telehealth technologies, and a few of them, such as urgent care, already were in the stage of testing. Everything changed in March 2020 when COVID-19 appeared. The state of emergency and stay-at-home orders introduced the need to keep at-risk patients out of healthcare facilities and at home whenever possible. In addition, new challenges included providing care to COVID-19 patients, preserving personal protective equipment and protecting the healthcare team’s own health. Read Full Article on Healthcare IT News >>
How AI is saving lives in stroke and other neurovascular care
November 29, 2022 / AI / Neurovascular / RapidAI – For more than 20 years, most in healthcare believed doctors had less than three hours after a stroke to provide treatment. However, Dr. Albers’ landmark research ultimately demonstrated that a thrombectomy (a procedure to remove blood clots) as late as 24 hours after stroke onset still benefited patients. Albers and Dr. Roland Bammer founded RapidAI to streamline the stroke workflow and get patients to treatment faster. Full Article on Healthcare IT News >>
New Mental Healthcare Solution for Companies and Employees
November 24, 2022 / Mental Healthcare / Ginger / Digital Mental Health – A year following its merger with Ginger, Headspace Health has launched another streamlined product experience that marries meditation and mindfulness solutions with Ginger’s sought-after coaching, counseling, and psychiatric services. Businesses continue to see a rise in mental health issues amongst their employees; addressing their psychological health concerns has turned into a key strategic objective. According to a research carried out earlier in the year by Headspace Health, 80% of employees reckon that the employer should support their employees with mental health problems. Read Full Article on Health Tech Insider >>
NTT, Harvard announce digital twin partnership to engineer the heart
November 30, 2022 / Harvard / Cardiovascular – Researchers are working to advance cardiac care through a cardiovascular bio digital twin model. They seek to explain the fundamental laws of the heart’s muscular pumps and other aspects of its function. The MEI Lab has focused on multi-scale precision cardiology platforms and heart-on-a-chip technology. It is developing the infrastructure for a digital replica of an individual’s heart while SEAS’ Disease Biophysics Group has been working for nearly 20 years toward the goal of engineering a human heart. Read Full Article on Healthcare IT News >>
Sweetwater Medical reduces patients’ blood pressure and weight with AI and RPM
November 30, 2022 / Sweetwater Medical / AI-enabled patient monitoring / RPM – Since the COVID-19 pandemic, Sweetwater has been perpetually short-staffed. The team always has seemed strapped for time, finding it challenging to monitor at-risk patients with hypertension and obesity to help manage their chronic conditions and look for signs of impending problems. “We serve lots of patients with chronic conditions, including hundreds with hypertension and obesity, and it’s crucial to get patient readings to better understand their condition,” said Eric Navarette, practice manager at Sweetwater Medical Associates. Read Full Article on Healthcare IT News >>

// Business & Markets

AbbVie links up with London VC firm to map out new anti-inflammatory companies
November 28, 2022 / AbbVie / Anti-inflammatory / Venture Capital / Inflammatory Diseases – AbbVie, which markets blockbuster rheumatoid arthritis drug Humira and has blockbuster follow-ups in Rinvoq and Skyrizi, will first work with DSV to identify areas of unmet need in the inflammatory area. DSV will then recruit a founding analyst to lead further development on new, curative therapeutic approaches for each selected area. “Approaches meeting the parties’ investment criteria will be spun out into new companies and both DSV and AbbVie will have the opportunity to provide pre-seed capital to the new companies at launch,” DSV explained in a release Nov. 28. Read Full Article on Fierce Biotech >>
With J&J’s Gorsky departing, Duato adopts dual role as chairman and CEO
December 1, 2022 / Alex Gorsky / Joaquin Duato / Johnson & Johnson – Duato, who took over as CEO this past January, will also become the company’s board chair in January 2023. At that time, Gorsky will part ways with J&J, the company said. As Gorsky officially departs from J&J, he “could not think of a better leader” than Duato to lead the board, the outgoing exec said in a statement. “The opportunity to lead Johnson & Johnson through such a pivotal time in the company’s history has been the great privilege of my life,” Gorsky said in the company’s statement. Read Full Article on Fierce Pharma >>
BioNTech adds STING to oncology portfolio in €40M small molecule licensing deal with Ryvu
November 30, 2022 / BioNTech / Ryvu Therapeutics / Small Molecules / Licensing Deals – Under the multi-target agreement, BioNtech will pay Ryvu 20 million euros ($20.7 million) upfront along with an equity investment of the same amount. Split into two parts, one side of the deal will see BioNTech secure an exclusive global license to develop and commercialize Ryvu’s STING agonist portfolio as standalone small molecules, including as monotherapies and in combination with other therapies. Read Full Article on Fierce Biotech >>
Black Friday for Spectrum as FDA lung cancer rejection prompts 75% cut to R&D workforce
November 28, 2022 / Spectrum Pharmaceuticals / Layoffs / Complete Response Letter / FDA – Spectrum Pharmaceuticals is ending the year as it started it—with a round of layoffs. Friday’s announcement of a 75% reduction in its R&D workforce has been prompted by a complete response letter from the FDA that provided the final nail in the coffin for the biotech’s ambitions for its lung cancer candidate Pozenveo. The writing was already on the wall for the oral tyrosine kinase inhibitor, also called poziotinib, in September when the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 that Pozenveo’s benefits don’t outweigh its risks when it comes to treating locally advanced or metastatic non-small cell lung cancer in patients harboring the human epidermal growth factor receptor exon 20 insertion mutation. The FDA’s thinking was made clear in a document released ahead of the committee’s meeting, which cited concerns regarding dosing and efficacy. Read Full Article on Fierce Biotech >>
Argenx hands bluebird $102M for FDA speedy review voucher
November 30, 2022 / Argenx / Bluebird Bio / Priority Review Voucher – Bluebird bio has sold argenx a rare pediatric disease priority review voucher (PRV) for $102 million, the companies said Wednesday. Bluebird got its hands on a pair of PRVs following the U.S. approval of its beta thalassemia gene therapy Zynteglo in August, plus its green light for Skysona in the rare neurological disorder cerebral adrenoleukodystrophy (CALD) in September. For its part, argenx specified that the FDA voucher will go toward a future marketing application for its first-in-class Fc receptor blocker efgartigimod. The drug snagged its initial U.S. green light as Vyvgart in generalized myasthenia gravis (gMG) in December 2021. Read Full Article on Fierce Pharma >>

// Legal & Regulatory

FDA shelves Eli Lilly’s COVID antibody bebtelovimab as evasive subvariants take hold
December 1, 2022 / Eli Lilly / Bebtelovimab / COVID-19 / Antibodies – Wednesday, Eli Lilly’s bebtelovimab became the latest COVID-19 treatment to get its emergency use authorization pulled by the FDA. In doing so, the agency cited data showing the antibody struggles with the omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is “not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.” the FDA said in a recent statement. For its part, Lilly said it agrees with the agency’s assessment and has paused commercial distribution of the antibody until further notice. Read on Fierce Pharma >>
Eli Lilly dumps Innovent’s PD-1 after FDA rebuff, nixing high-profile Chinese cancer drug
December 1, 2022 / Eli Lilly / PD-1/L1 / Innovent Biologics / Non-small Cell Lung Cancer – Eli Lilly has officially given up ex-China rights to Innovent Biologics’ Tyvyt, a PD-1 inhibitor that was once billed as a potential low-cost choice in a multibillion-dollar class. The drug was also the poster child in a group of China-developed medicines that drew Big Pharma interest. Lilly terminated the Tyvyt deal covering geographies outside of China and kicked the drug back to Innovent in October, the Indianapolis pharma said in its third-quarter securities filing. Read on Fierce Pharma >>
Pfizer CEO Bourla stung by UK’s pharma marketing regulator over kids’ COVID vax claims: report
November 28, 2022 / Pfizer / Comirnaty / COVID-19 / Adult Vaccines – That’s the latest finding in an ongoing case at the British pharmaceutical marketing regulator the Prescription Medicines Code of Practice Authority (PMCPA), The Telegraph reports. In an interview with the BBC on Dec. 2, 2021, Bourla said “there is no doubt in my mind that the benefits, completely, are in favour of” vaccinating youngsters ages 5 to 11 against COVID. He added that: “COVID in schools is thriving […] This is disturbing, significantly, the educational system, and there are kids that will have severe symptoms.” Read on Fierce Pharma >>
Roche pulls another FDA accelerated approval for cancer drug Tecentriq
November 29, 2022 / Roche / Tecentriq / Bladder Cancer / Genentech – A week after GSK sidelined its multiple myeloma drug Blenrep, following a confirmatory trial failure, Roche has done the same for a key indication of its blockbuster cancer drug Tecentriq. Following consultation with the FDA, Roche has withdrawn Tecentriq’s use as a first-line treatment for a form of advanced bladder cancer. The move, like that for Blenrep, is another in a growing list of accelerated approvals that have been overturned because of doubts raised in post-approval confirmatory trials. Read on Fierce Pharma >>
FDA approves first fecal microbiome drug, setting stage for others
November 30, 2022 / FDA / Microbiome Drug / Rebyota – he Food and Drug Administration approved the first therapy using bacteria from stool samples to treat a bowel disorder on Wednesday, paving the way for several similar treatments in development. The drug, called Rebyota, is given as a one-dose treatment for Clostridium difficile infections, commonly known as C. diff., in which the toxin-producing bacteria disrupts the normal balance in a person’s digestive system. Rebyota is designed to restore balance by introducing good bacteria taken from donor stool samples. Read on STAT News >>

// Research & Development

J&J unit, happy with AC Immune Alzheimer’s work, moves 1 of 2 shots to next step
November 30, 2022 / AC Immune / Janssen / Alzheimer’s / Anti-Tau – As the pharma world chatters about the merits of the amyloid theory in Alzheimer’s disease, Johnson & Johnson is taking things in another direction. The healthcare giant’s pharmaceutical unit Janssen has picked a tau vaccine from its collaboration with neurodegenerative-focused biotech AC Immune to advance into further development. That means that another shot in development by the pair, JACI-35.054, will not move forward. The two vaccines had been tested head-to-head and ultimately, the candidate called ACI-35.030 was the winner, a spokesperson for AC Immune confirmed to Fierce Biotech. Read Full Article on Fierce Biotech>>
Pfizer-Valneva’s Lyme vaccine triggers 6-month antibody response, validating phase 3 regimen
December 1, 2022 / Pfizer / Valneva / Lyme Disease / Vaccine – Pfizer and Valneva have added another plank of evidence in support of their Lyme disease vaccine candidate, revealing antibody levels remained elevated six months after the completion of dosing in a phase 2 clinical trial. The study randomized 585 people aged between 5 and 65 years to take a two- or three-dose course of the vaccine, VLA15, or placebo. Pfizer and Valneva reported immunogenicity and safety data from the clinical trial earlier this year and continued to track participants after the initial period to gather more information about the persistence of the antibody response. Read Full Article on Fierce Biotech >>
Roche thins Alzheimer’s program after phase 3 failure, may seek ‘external partnerships’
December 1, 2022 / Genentech / Alzheimer’s Disease / Gantenerumab / Roche – Roche’s Genentech unit is walking away from a clutch of studies for its leading Alzheimer’s therapy gantenerumab, weeks after the monoclonal antibody failed a pair of phase 3 studies. Reuters reported the decision to cut the programs Wednesday evening, but the writing was on the wall after gantenerumab failed to improve cognitive and functional decline in the two much-anticipated trials from the Graduate program in November. The miss was called a “resounding failure for gantenerumab,” by analysts. Read Full Article on Fierce Biotech >>
Viatris pulls decades-old accelerated approval thanks to ‘unfeasible’ confirmatory trial demand
November 30, 2022 / U.S. FDA / Accelerated Approval / Viatris / Antibiotics – The FDA has been cleaning up its act around accelerated approvals lately, pressuring companies to pull drugs that don’t meet their confirmatory trial requirements. Now, one more therapy has fallen from grace almost 25 years after its original go-ahead. The FDA is withdrawing the accelerated approval for Mylan’s legacy antimicrobial powder Sulfamylon following a request by Mylan’s parent company Viatris, the agency said in a public filing (PDF). This is separate from a Sulfamylon cream that won approval in 1969. Read Full Article on Fierce Pharma >>
Rallybio revs up antibody discovery activities with risk-sharing AbCellera pact
December 1, 2022 / Rallybio / AbCellera / Rare Diseases / Antibodies – Rallybio has become the latest company to hitch its antibody drug development efforts to AbCellera. The partners will co-develop up to five rare disease therapeutic targets in a risk-sharing pact, starting with a metabolic disease program. AbCellera, a biotech perhaps best known for its work on Eli Lilly’s COVID-19 antibodies, has signed up a string of drug developers as partners in recent years on the strength of its discovery platform. Rallybio has now added its name to that list by forming a multiyear, multitarget collaboration that could provide a stream of new programs for its pipeline. Read Full Article on Fierce Biotech >>

// Politics

Biden admin, industry huddle on outbound investment order
November 28, 2022 / Biden Admin / Investment Order / China / New Regulatory Power – Officials from the Commerce Department, National Security Council and other agencies have taken meetings with industry officials, allies and others over the past two months as they work to finalize new oversight for American firms in China. “The Biden administration continues to discuss with stakeholders, including industry, allies and partners, our ongoing deliberations to develop a carefully tailored approach to outbound investments in sensitive technologies,” said an NSC spokesperson, “particularly investments that would not be captured by export controls or other currently available tools, and could enhance the technological capabilities of our competitors in ways that undermine U.S and allied security.” Read Full Article on Politico >>
Pandemic and Politics Shaped Pharma and FDA in 2022
December 2, 2022 / FDA / Pandemic / Politics / Vaccines / Therapies – This past year has been marked by continued efforts to develop, regulate, and distribute important therapies and vaccines to treat lethal and rare diseases, including the still-dangerous COVID-19 virus. Despite generally high praise for biopharmaceutical companies in advancing these efforts, industry was unable to block the adoption of price controls for prescription drugs, a policy that risks limiting research in some areas. At the same time, the tense political environment leading up to the November mid-term Congressional elections blocked agreement on many important legislative and regulatory initiatives for FDA, delaying until the very last moment reauthorization of critical user fee programs to support the agency. Despite the anxiety generated by that cliff hanger, FDA succeeded in maintaining an efficient oversight and approval program for new and important therapies and issued multiple new guidances, renewed field inspections, and launched a range of initiatives to support public health. Read Full Article on PharmaTech >>
PBM lobby gears up for lawmaker scrutiny
November 29, 2022 / PBM / Lawmakers / Pharma Care Management Association – The common thread among health-centric lawmakers in both parties looking ahead to the 118th Congress is an increased focus on pharmacy benefit managers and the role they play in setting U.S. drug prices. While few specifics have been revealed about how members will dig into the industry, its main lobbying group, the Pharmaceutical Care Management Association, is preparing for a year of oversight overtures. PCMA President and CEO JC Scott recently sat down with your co-host and POLITICO’s Megan R. Wilson to preview the group’s 2023 strategy. Here are some highlights: Read Full Article on Politico >>
Government plans to freeze drug prices
December 1, 2022 / Government / Drug Prices – The minister guaranteed that the Government is attentive to the cost of medicines, stressing that, in terms of inflation, there is no influence on prices of medications. “The problem with medicines is another: It is to know if, in some cases, the degradation of their price does not contribute to their shortage in the market”, considered the minister. Read Full Article on The Portugal News >>