New York Archives - MedCity News https://medcitynews.com/tag/new-york/ Healthcare technology news, life science current events Thu, 28 Sep 2023 01:33:46 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.1 https://medcitynews.com/uploads/2021/03/cropped-mblue-32x32.png New York Archives - MedCity News https://medcitynews.com/tag/new-york/ 32 32 40682243 Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy https://medcitynews.com/2023/09/fda-advisory-committee-brainstorm-cell-therapeutics-als-stem-cell-therapy/ https://medcitynews.com/2023/09/fda-advisory-committee-brainstorm-cell-therapeutics-als-stem-cell-therapy/#respond Thu, 28 Sep 2023 01:33:46 +0000 https://medcitynews.com/?p=650064

NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

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After NASH Hopes Are Dashed, Intercept Pharma Agrees to $794M Buyout https://medcitynews.com/2023/09/after-nash-hopes-are-dashed-intercept-pharma-agrees-to-794m-buyout/ https://medcitynews.com/2023/09/after-nash-hopes-are-dashed-intercept-pharma-agrees-to-794m-buyout/#respond Tue, 26 Sep 2023 17:22:56 +0000 https://medcitynews.com/?p=649905

Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.

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Click Expands to Substance Use Disorder With Indivior Digital Therapeutics Pact https://medcitynews.com/2023/09/digital-therapeutic-substance-use-disorder-indivior-click-therapeutics/ https://medcitynews.com/2023/09/digital-therapeutic-substance-use-disorder-indivior-click-therapeutics/#respond Sun, 10 Sep 2023 12:36:14 +0000 https://medcitynews.com/?p=648099

Digital therapeutics developer Click Therapeutics is partnering with Indivior to develop a mobile app for substance use disorder. Indivior is now Click’s third development partner, following deals with Boehringer Ingelheim and Otsuka Pharmaceutical.

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GSK Patent Suit Aims to Halt Pfizer’s RSV Vaccine for Adults, But Not Infants https://medcitynews.com/2023/08/gsk-pfizer-rsv-vaccine-patent-lawsuit-arexvy-abrysvo/ https://medcitynews.com/2023/08/gsk-pfizer-rsv-vaccine-patent-lawsuit-arexvy-abrysvo/#respond Thu, 03 Aug 2023 19:13:27 +0000 https://medcitynews.com/?p=643977

GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.

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TG Therapeutics Lands Partner to Market MS Drug in Europe and Beyond https://medcitynews.com/2023/08/multiple-sclerosis-drug-relapsing-ms-tg-therapeutics-neuraxpharm/ https://medcitynews.com/2023/08/multiple-sclerosis-drug-relapsing-ms-tg-therapeutics-neuraxpharm/#respond Tue, 01 Aug 2023 22:31:17 +0000 https://medcitynews.com/?p=643734

TG Therapeutics’ multiple sclerosis drug Briumvi will be commercialized in Europe by Neuraxpharm. The Germany-based company paid $140 million up front for certain rights to the drug, which received European Commission approval in June.

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FDA Approval of Pfizer Alopecia Drug Brings New Competition to Eli Lilly Med https://medcitynews.com/2023/06/fda-approval-pfizer-alopecia-areata-drug/ https://medcitynews.com/2023/06/fda-approval-pfizer-alopecia-areata-drug/#respond Mon, 26 Jun 2023 21:13:19 +0000 https://medcitynews.com/?p=639513

Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.

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Pfizer Hemophilia Drug Reduces Bleeding in Key Study; Regulatory Filings Are Planned https://medcitynews.com/2023/05/pfizer-hemophilia-antibody-drug-bleeding-clinical-trial/ https://medcitynews.com/2023/05/pfizer-hemophilia-antibody-drug-bleeding-clinical-trial/#respond Tue, 30 May 2023 16:53:53 +0000 https://medcitynews.com/?p=636286

Marstacimab, a Pfizer drug for both hemophilia A and B, met the main goal of a Phase 3 study and the company now plans to discuss the data with regulators. The Pfizer drug could beat to the market a Novo Nordisk drug that addresses the same novel target.

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Labcorp Shells Out $146M to Buy Enzo Biochem’s Clinical Lab Business https://medcitynews.com/2023/03/labcorp-shells-out-146m-to-buy-enzo-biochems-clinical-lab-business/ https://medcitynews.com/2023/03/labcorp-shells-out-146m-to-buy-enzo-biochems-clinical-lab-business/#respond Fri, 17 Mar 2023 19:55:06 +0000 https://medcitynews.com/?p=627921

Enzo BioChem’s sale of its clinical lab business to Labcorp is the culmination of a monthslong strategic review. Meanwhile, diagnostics and lab testing giant Labcorp is in the middle of its own corporate shakeup as it readies its clinical trials business for a spinoff as a standalone, publicly traded company.

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Pfizer’s Migraine Drug Approval Triggers $475M Payment to Royalty Pharma https://medcitynews.com/2023/03/pfizers-migraine-drug-approval-triggers-475m-payment-to-royalty-pharma/ https://medcitynews.com/2023/03/pfizers-migraine-drug-approval-triggers-475m-payment-to-royalty-pharma/#respond Thu, 16 Mar 2023 20:36:16 +0000 https://medcitynews.com/?p=627822

Royalty Pharma’s milestone payment from the approval of Pfizer migraine drug Zavzpret stems from financing deals struck with the therapy’s previous developer, Biohaven Pharmaceuticals. Royalty Pharma is also in line to receive royalty payments going beyond the next decade.

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Pfizer’s Seagen Acquisition Brings It Full Circle in a Hot Area of Cancer Drug R&D https://medcitynews.com/2023/03/pfizers-seagen-acquisition-brings-it-full-circle-in-a-hot-area-of-cancer-drug-rd/ https://medcitynews.com/2023/03/pfizers-seagen-acquisition-brings-it-full-circle-in-a-hot-area-of-cancer-drug-rd/#respond Wed, 15 Mar 2023 11:30:39 +0000 https://medcitynews.com/?p=627495 lymphoma

Pfizer is no stranger to antibody drug conjugate cancer therapies, but it hasn’t been commercially successful with them. The pharma giant’s agreement to acquire Seagen for $43 billion will thrust it to the forefront of the ADC drug class, which has become a hot space for research and regulatory activity in recent years.

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Where Big Pharmas Faltered, Stemline Succeeds and Lands FDA Nod in Breast Cancer https://medcitynews.com/2023/01/where-big-pharmas-faltered-stemline-succeeds-and-lands-fda-nod-in-breast-cancer/ https://medcitynews.com/2023/01/where-big-pharmas-faltered-stemline-succeeds-and-lands-fda-nod-in-breast-cancer/#respond Wed, 01 Feb 2023 00:22:47 +0000 https://medcitynews.com/?p=622516

Orserdu, a drug from Menarini Group subsidiary Stemline Therapeutics, is now approved for treating breast cancers that carry the ESR1 mutation. The drug is the first approved oral therapy from a class of therapies called selective estrogen receptor degraders (SERDs).

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FDA Again Spurns BrainStorm’s ALS Data, This Time With Official Refusal https://medcitynews.com/2022/11/fda-again-spurns-brainstorms-als-data-this-time-with-official-refusal/ https://medcitynews.com/2022/11/fda-again-spurns-brainstorms-als-data-this-time-with-official-refusal/#respond Thu, 10 Nov 2022 19:50:12 +0000 https://medcitynews.com/?p=613072

BrainStorm Cell Therapeutics’ stem cell therapy for amyotrophic lateral sclerosis received an FDA refuse-to-file letter, correspondence that informs a company its application seeking approval is incomplete. The notice means BrainStorm might need to run another clinical trial.

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Sanofi Inks Another AI Alliance, This Time Partnering With Insilico Medicine https://medcitynews.com/2022/11/sanofi-inks-another-ai-alliance-this-time-partnering-with-insilico-medicine/ https://medcitynews.com/2022/11/sanofi-inks-another-ai-alliance-this-time-partnering-with-insilico-medicine/#respond Tue, 08 Nov 2022 17:10:49 +0000 https://medcitynews.com/?p=612616

Sanofi will use Insilico Medicine’s tech to advance drug development candidates for up to six new targets. Disease indications were not disclosed, but the pharmaceutical giant said the new agreement will boost its drug discovery research in China.

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Pfizer RSV Vaccine Hits Trial Goal for Infants; Year-End FDA Filing Planned https://medcitynews.com/2022/11/pfizer-rsv-vaccine-hits-trial-goal-for-infants-year-end-fda-filing-planned/ https://medcitynews.com/2022/11/pfizer-rsv-vaccine-hits-trial-goal-for-infants-year-end-fda-filing-planned/#respond Tue, 01 Nov 2022 18:57:20 +0000 https://medcitynews.com/?p=611242

Pfizer’s respiratory syncytial virus vaccine candidate infants has clinical data showing it helped prevent severe infections in infants. It’s a maternal vaccine that produces antibodies in the mother that confer temporary protection to a baby.

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Sanofi exec jumps to Owkin to ramp up the AI biotech’s pharma partnership plans https://medcitynews.com/2022/10/sanofi-exec-jumps-to-owkin-to-ramp-up-the-ai-biotechs-pharma-partnership-plans/ https://medcitynews.com/2022/10/sanofi-exec-jumps-to-owkin-to-ramp-up-the-ai-biotechs-pharma-partnership-plans/#respond Tue, 04 Oct 2022 22:40:37 +0000 https://medcitynews.com/?p=607159

Alban de La Sablière, global head of partnering at Sanofi for the past six years, has joined artificial intelligence biotech Owkin as its first chief business officer. In addition to finding more business partnerships, de La Sablière will also oversee expansion of Owkin’s internal drug and diagnostics pipeline.

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Witnesses recount ‘dire conditions’ in nursing homes during Covid-19 in congressional hearing https://medcitynews.com/2022/09/witnesses-recount-dire-conditions-in-nursing-homes-during-covid-19-in-congressional-hearing/ https://medcitynews.com/2022/09/witnesses-recount-dire-conditions-in-nursing-homes-during-covid-19-in-congressional-hearing/#respond Fri, 23 Sep 2022 22:45:54 +0000 https://medcitynews.com/?p=605788

A professor of healthcare policy at Harvard Medical School shared research with the committee concluding that COVID-19 outbreaks in nursing homes were largely a function of where in the country a nursing home was located versus other specifics about the facility. 

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Pfizer, BioNTech seek FDA authorization for omicron-adjusted Covid-19 boosters https://medcitynews.com/2022/08/pfizer-biontech-seek-fda-authorization-for-omicron-adjusted-covid-19-boosters/ https://medcitynews.com/2022/08/pfizer-biontech-seek-fda-authorization-for-omicron-adjusted-covid-19-boosters/#respond Mon, 22 Aug 2022 20:28:48 +0000 https://medcitynews.com/?p=601099

Pfizer and BioNTech have completed their filing seeking FDA emergency use authorization of their omicron-adapted Covid-19 booster shot. Production of this bivalent vaccine has already begun, enabling the companies to begin distribution as soon as the FDA authorizes the shot.

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Better late than never? Axsome depression drug is approved a year after FDA delay https://medcitynews.com/2022/08/better-late-than-never-axsome-depression-drug-is-approved-a-year-after-fda-delay/ https://medcitynews.com/2022/08/better-late-than-never-axsome-depression-drug-is-approved-a-year-after-fda-delay/#respond Fri, 19 Aug 2022 19:01:49 +0000 https://medcitynews.com/?p=600952

The FDA has approved Axsome Therapeutics drug Auvelity as a treatment for major depressive disorder in adults. The regulatory decision makes the twice-daily pill the first new oral drug approved to address a novel depression target in more than 60 years.

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Pfizer to buy sickle cell disease biotech Global Blood Therapeutics in $5.4B deal https://medcitynews.com/2022/08/pfizer-to-buy-sickle-cell-disease-biotech-global-blood-therapeutics-in-5-4b-deal/ https://medcitynews.com/2022/08/pfizer-to-buy-sickle-cell-disease-biotech-global-blood-therapeutics-in-5-4b-deal/#respond Mon, 08 Aug 2022 16:18:57 +0000 https://medcitynews.com/?p=598568

Pfizer’s own R&D efforts in sickle cell disease have fallen short, so the pharmaceutical giant is turning to M&A to gain a presence in the blood disorder. The acquisition of Global Blood therapeutics brings the commercialized drug Oxbryta plus a pipeline of other therapeutic candidates.

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Regeneron is paying $900M for full rights to cancer drug partnered with Sanofi https://medcitynews.com/2022/06/regeneron-is-paying-900m-for-full-rights-to-cancer-drug-partnered-with-sanofi/ https://medcitynews.com/2022/06/regeneron-is-paying-900m-for-full-rights-to-cancer-drug-partnered-with-sanofi/#respond Thu, 02 Jun 2022 21:30:39 +0000 https://medcitynews.com/?p=589940

Regeneron Pharmaceuticals has big plans for cancer immunotherapy Libtayo and it believes it can better execute on them if it has full control of the drug, currently partnered with Sanofi. Regeneron struck a deal to pay Sanofi $900 million, plus another $200 million in milestones, to secure full global rights to the asset.

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After Haleon splits from GSK, Pfizer plans to cash out to the tune of $16B https://medcitynews.com/2022/06/after-haleon-splits-from-gsk-pfizer-plans-to-cash-out-to-the-tune-of-16b/ https://medcitynews.com/2022/06/after-haleon-splits-from-gsk-pfizer-plans-to-cash-out-to-the-tune-of-16b/#respond Wed, 01 Jun 2022 17:03:53 +0000 https://medcitynews.com/?p=589676

When consumer healthcare products joint venture Haleon spins out from GSK as an independent company next month, Pfizer will sell its minority stake in the business. Pfizer said that selling its ownership in Haleon is keeping with its focus on developing innovative new medicines and vaccines.

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Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease https://medcitynews.com/2022/04/potential-blockbuster-bms-cardio-drug-gets-fda-nod-first-in-rare-heart-disease/ https://medcitynews.com/2022/04/potential-blockbuster-bms-cardio-drug-gets-fda-nod-first-in-rare-heart-disease/#respond Fri, 29 Apr 2022 16:36:05 +0000 https://medcitynews.com/?p=585213 Image of heart and circulatory system

Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.

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Regeneron captures new piece for cancer with $250M Checkmate Pharma buyout https://medcitynews.com/2022/04/regeneron-captures-new-piece-for-cancer-with-250m-checkmate-pharma-buyout/ https://medcitynews.com/2022/04/regeneron-captures-new-piece-for-cancer-with-250m-checkmate-pharma-buyout/#respond Tue, 19 Apr 2022 18:14:55 +0000 https://medcitynews.com/?p=583377

Regeneron Pharmaceuticals is paying $250 million cash to acquire Checkmate Pharmaceuticals, a clinical-stage biotech developing drugs that activate the innate immune system. The biotech’s lead drug candidate is currently in pivotal testing in melanoma.

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BMS nabs FDA nod for first drug in new class of cancer immunotherapies https://medcitynews.com/2022/03/bms-nabs-fda-nod-for-first-drug-in-new-class-of-cancer-immunotherapies/ https://medcitynews.com/2022/03/bms-nabs-fda-nod-for-first-drug-in-new-class-of-cancer-immunotherapies/#respond Mon, 21 Mar 2022 10:00:41 +0000 https://medcitynews.com/?p=578445 metastatic melanoma

Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The drug is approved for advanced melanoma as part of a combination treatment that includes the already approved BMS cancer immunotherapy Opdivo.

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Sanofi and DarioHealth team up on digital health tools for chronic conditions https://medcitynews.com/2022/03/sanofi-and-dariohealth-team-up-on-digital-health-tools-for-chronic-conditions/ https://medcitynews.com/2022/03/sanofi-and-dariohealth-team-up-on-digital-health-tools-for-chronic-conditions/#respond Tue, 01 Mar 2022 21:11:37 +0000 https://medcitynews.com/?p=574398 digital health smartphone

Sanofi and digital therapeutics company DarioHealth will work together to promote the tech firm’s offerings for the management of chronic diseases. Under the $30 million, multi-year agreement, the partners will also develop new technology tools.

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Pfizer bows out of developing cardio drug, returns rights to Ionis Pharmaceuticals https://medcitynews.com/2022/01/pfizer-bows-out-of-developing-cardio-drug-returns-rights-to-partner-ionis-pharmaceuticals/ https://medcitynews.com/2022/01/pfizer-bows-out-of-developing-cardio-drug-returns-rights-to-partner-ionis-pharmaceuticals/#respond Tue, 01 Feb 2022 00:34:33 +0000 https://medcitynews.com/?p=568678

After reviewing Phase 2B clinical data, the New York drugmaker and its partner Ionis Pharmaceuticals announced that Pfizer was abandoning the development of a cardiovascular drug, thereby returning the rights to Ionis.

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Clinical trials startup comes out of stealth by announcing $27.5M funding round https://medcitynews.com/2022/01/clinical-trails-startup-launches-out-of-stealth-with-27-5-million-series-a-funding/ https://medcitynews.com/2022/01/clinical-trails-startup-launches-out-of-stealth-with-27-5-million-series-a-funding/#respond Sun, 30 Jan 2022 22:15:26 +0000 https://medcitynews.com/?p=567334

Topography Health announced their 27.5M series A funding for their clinical trials technology led by Andreessen Horowitz and Bain Capital Ventures.

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Medidata talent acquisition director highlights AI job growth https://medcitynews.com/2022/01/medidata-talent-acquisition-director-highlights-ai-job-growth/ https://medcitynews.com/2022/01/medidata-talent-acquisition-director-highlights-ai-job-growth/#respond Thu, 27 Jan 2022 16:03:36 +0000 https://medcitynews.com/?p=568012

Andrew Bott, Director of Talent Acquisition in EMEA & APAC countries at Medidata, shared his insights on hiring trends in this sector, in response to emailed questions.

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Pfizer’s growth hormone deficiency drug comes up short at the FDA https://medcitynews.com/2022/01/pfizers-growth-hormone-deficiency-drug-comes-up-short-at-the-fda/ https://medcitynews.com/2022/01/pfizers-growth-hormone-deficiency-drug-comes-up-short-at-the-fda/#respond Sun, 23 Jan 2022 13:01:30 +0000 https://medcitynews.com/?p=567205

The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Pharma that is also designed for once-weekly dosing.

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Psychedelic biotech Eleusis enters SPAC deal to take depression drug to the clinic https://medcitynews.com/2022/01/psychedelic-biotech-eleusis-enters-spac-deal-to-take-depression-drug-to-the-clinic/ https://medcitynews.com/2022/01/psychedelic-biotech-eleusis-enters-spac-deal-to-take-depression-drug-to-the-clinic/#respond Fri, 21 Jan 2022 00:51:15 +0000 https://medcitynews.com/?p=566932

Eleusis is developing a formulation of the psychedelic compound psilocybin that overcomes limitations of pill versions of the drug. Depression is Eleusis’s lead disease target but the biotech notes that its research has shown the potential to bring psychedelic drugs beyond psychiatry.

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