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Independent news organization reporting daily on biotech and pharma R&D – covers breaking industry news, business deals, FDA actions, and clinical trial results.

Design Therapeutics' Friedreich's Ataxia Data; Vincentage's Obesity Results From China
NewsMay 18, 2026

Design Therapeutics' Friedreich's Ataxia Data; Vincentage's Obesity Results From China

Design Therapeutics disclosed Phase 1/2 results for its Friedreich's ataxia candidate DT‑216P2, administered at 1 mg/kg. Patients experienced an average 6.4‑point improvement on the disease‑specific functional scale, with safety comparable to placebo and no serious adverse events reported. The trial enrolled roughly...

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Merck's ADC Sac-TMT Gets Its First Global Phase 3 Win Ahead of Schedule
NewsMay 18, 2026

Merck's ADC Sac-TMT Gets Its First Global Phase 3 Win Ahead of Schedule

Merck and China‑based Kelun‑Biotech announced that their experimental antibody‑drug conjugate sac‑TMT achieved its primary endpoint in a global Phase 3 trial, completing ahead of schedule. The study enrolled roughly 650 patients with advanced solid tumours across 12 countries and demonstrated a...

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The Supreme Court Won't Take up Drugmakers' IRA Cases
NewsMay 18, 2026

The Supreme Court Won't Take up Drugmakers' IRA Cases

The U.S. Supreme Court declined to hear several lawsuits filed by major drugmakers challenging the Medicare drug‑price negotiation provisions of the Inflation Reduction Act. The cases, brought by AstraZeneca, Johnson & Johnson and other manufacturers, sought to block the administration’s...

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Biopharma M&A Maintains Strength Even as Large Deals Wane
NewsMay 15, 2026

Biopharma M&A Maintains Strength Even as Large Deals Wane

Biopharma merger‑and‑acquisition activity remains robust, driven by companies scrambling to replace revenue lost to looming patent expiries. Deal volume rose about 15% year‑over‑year, pushing total transaction value to roughly $45 billion in the last twelve months. However, the market has seen...

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Amgen Expands Crackdown on What It Says Is Misuse of 340B Program
NewsMay 15, 2026

Amgen Expands Crackdown on What It Says Is Misuse of 340B Program

Amgen announced it will broaden its data‑submission requirements for pharmacies that dispense its products under the federal 340B drug discount program. The new policy mandates that participating pharmacies provide detailed claims data for every prescription, aiming to curb what Amgen...

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Candel Reports Prostate Cancer Drug's Long-Term Data Ahead of FDA Filing
NewsMay 15, 2026

Candel Reports Prostate Cancer Drug's Long-Term Data Ahead of FDA Filing

Candel Therapeutics released long‑term follow‑up results for its investigational prostate cancer therapy, showing durable efficacy and a favorable safety profile. The data reveal a 78% five‑year disease‑free survival rate and a median PSA decline of over 90% in the majority...

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Aardvark's Next Move After Clinical Hold; Alumis' Verdict on Acelyrin Asset
NewsMay 15, 2026

Aardvark's Next Move After Clinical Hold; Alumis' Verdict on Acelyrin Asset

Aardvark Therapeutics announced that the FDA clinical hold on its rare‑disease HERO and OLE studies has been lifted, allowing the company to unblind the trial data. The unblinding will provide critical efficacy and safety readouts for the targeted condition. In...

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M&A Isn’t Just for Big Pharma. Mid-Size Companies Are Stepping up Deal Hunts
NewsMay 15, 2026

M&A Isn’t Just for Big Pharma. Mid-Size Companies Are Stepping up Deal Hunts

Mid‑size biopharma firms are leading a surge in mergers and acquisitions, making 2024 the most active year on record for the sector. American mid‑cap drugmakers have mobilized roughly $4 billion in capital, while family‑owned groups and foundation‑governed European companies are also...

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Andrea Pfeifer Ends 23-Year Reign at AC Immune; Acadia's Top R&D Exec Announces Retirement
NewsMay 15, 2026

Andrea Pfeifer Ends 23-Year Reign at AC Immune; Acadia's Top R&D Exec Announces Retirement

AC Immune announced that its chief executive, Dr. Andrea Pfeifer, will retire at the upcoming annual general meeting, ending a 23‑year tenure. The board will launch a search for a new CEO, marking the first time the company has sought a...

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#ASGCT26: A Zillow-Like Marketplace for Abandoned Gene Therapies Goes Live
NewsMay 15, 2026

#ASGCT26: A Zillow-Like Marketplace for Abandoned Gene Therapies Goes Live

Two nonprofit groups, the American Society of Gene & Cell Therapy and the Orphan Therapeutics Accelerator, unveiled a Zillow‑style online marketplace that lists abandoned cell and gene therapy assets. The platform, launched at the ASGCT26 conference, aggregates more than 30...

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Encoded's Gene Therapy Reduced Seizures in Dravet Syndrome
NewsMay 14, 2026

Encoded's Gene Therapy Reduced Seizures in Dravet Syndrome

Encoded Therapeutics reported that its experimental gene therapy cut seizure frequency by 76 % in three children with Dravet syndrome, a severe childhood epilepsy. The effect was seen in patients receiving the second‑highest dose among four dose levels in a small...

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ASGCT Dispatch: In Vivo CAR-T Is Everywhere
NewsMay 14, 2026

ASGCT Dispatch: In Vivo CAR-T Is Everywhere

At the American Society of Gene & Cell Therapy (ASGCT) meeting in Boston, developers showcased a wave of in vivo CAR‑T programs, signaling a shift from traditional ex‑vivo manufacturing. Companies unveiled preclinical and early‑phase clinical data demonstrating tumor shrinkage using...

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Degron, CREATE, TenNor Raise Capital; Cabaletta Posts CAR-T Data
NewsMay 14, 2026

Degron, CREATE, TenNor Raise Capital; Cabaletta Posts CAR-T Data

Degron Therapeutics announced a $40 million Series A extension, bringing its total raise to $95 million to advance its molecular‑glue degrader platform. At the same time, biotech firms CREATE and TenNor disclosed fresh capital infusions to fuel pipeline development. Cabaletta Bio reported early...

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AstraZeneca Follows Merck with Phase 3 Win in Bladder Cancer
NewsMay 14, 2026

AstraZeneca Follows Merck with Phase 3 Win in Bladder Cancer

AstraZeneca announced that its checkpoint inhibitor Imfinzi, co‑developed with Pfizer, combined with Astellas’ antibody‑drug conjugate Padcev, significantly extended overall survival in a Phase 3 trial for advanced bladder cancer. The regimen outperformed the current standard of care, marking the company’s second...

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MacroGenics Sells Manufacturing Arm; West Pharma Discloses Cybersecurity Attack
NewsMay 14, 2026

MacroGenics Sells Manufacturing Arm; West Pharma Discloses Cybersecurity Attack

MacroGenics announced the sale of its GMP‑manufacturing operations to Bora Pharmaceuticals, shifting its focus back to early‑stage antibody development. The transaction, terms undisclosed, transfers a fully qualified production suite and associated staff. In parallel, West Pharma disclosed a recent cybersecurity...

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How Penn Medicine Plans to Use AI to Train Their Doctors
NewsMay 14, 2026

How Penn Medicine Plans to Use AI to Train Their Doctors

Penn Medicine secured a $1.1 million American Medical Association education grant to develop AI‑driven tools that give medical trainees real‑time feedback on clinical reasoning. The project will deploy ambient artificial intelligence to record and analyze both peer‑to‑peer and patient‑facing conversations, using...

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BeOne’s Next-Gen BCL2 Inhibitor Wins FDA Approval, Taking Aim at Venclexta
NewsMay 14, 2026

BeOne’s Next-Gen BCL2 Inhibitor Wins FDA Approval, Taking Aim at Venclexta

BeOne Medicines received accelerated FDA approval for sonrotoclax, its next‑generation BCL‑2 inhibitor, for mantle cell lymphoma. The decision rests on a single‑arm trial that delivered a 68% overall response rate in heavily pre‑treated patients. Sonrotoclax is positioned to compete directly...

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Lilly Points to Low-Dose Zepbound and Foundayo as Weight Loss Maintenance Options
NewsMay 12, 2026

Lilly Points to Low-Dose Zepbound and Foundayo as Weight Loss Maintenance Options

Eli Lilly’s phase‑III trial indicates that a reduced dose of its obesity injectable Zepbound can sustain weight loss while improving safety and lowering costs. The study also highlighted Foundayo, an oral GLP‑1 candidate, as a viable maintenance therapy for patients preferring...

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EU Reaches Provisional Deal on Critical Medicines Act
NewsMay 12, 2026

EU Reaches Provisional Deal on Critical Medicines Act

The European Parliament and Council have provisionally approved the Critical Medicines Act, marking a key step toward legislation aimed at safeguarding the EU’s supply of essential drugs. The proposal introduces mandatory stockpiles, an early‑warning system for shortages, and financial incentives...

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Five Burning Qs for Isomorphic Labs After $2.1B Raise for AI Biotech
NewsMay 12, 2026

Five Burning Qs for Isomorphic Labs After $2.1B Raise for AI Biotech

Isomorphic Labs announced a $2.1 billion Series B round, the second‑largest private biotech raise ever recorded. The funding, led by SoftBank Vision Fund, Temasek and Alphabet’s GV, will accelerate its AI‑driven drug‑discovery platform that leverages protein‑folding models. The capital injection expands Isomorphic's...

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Pfizer and Arvinas Give Disappointing Breast Cancer Drug to Rigel
NewsMay 12, 2026

Pfizer and Arvinas Give Disappointing Breast Cancer Drug to Rigel

Pfizer and biotech partner Arvinas have agreed to sell the U.S. commercial rights to their newly approved breast‑cancer therapy to Rigel Pharmaceuticals for $35 million. The transaction marks a steep de‑valuation, turning an initial $1 billion investment into a modest cash infusion....

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Bayer to Make 'Careful but Aggressive' Return to Pharma M&A, CEO Says
NewsMay 12, 2026

Bayer to Make 'Careful but Aggressive' Return to Pharma M&A, CEO Says

Bayer announced it is re‑entering the pharmaceutical merger‑and‑acquisition market after a five‑year pause, signaling a shift from its traditional focus on crop chemicals. CEO Bill Anderson described the approach as "careful but aggressive," aiming to secure high‑value drug assets while...

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Alkermes' Narcolepsy Phase 3 Success; Boehringer's Antibody Deal
NewsMay 12, 2026

Alkermes' Narcolepsy Phase 3 Success; Boehringer's Antibody Deal

Alkermes announced that its narcolepsy candidate Lumryz achieved its primary and key secondary endpoints in a pivotal Phase 3 trial, demonstrating statistically significant reductions in cataplexy attacks and excessive daytime sleepiness. The study enrolled 500 patients across North America and Europe...

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Knit Health Raises $11.6M for 'Fundamentally Different' Approach to Healthcare AI
NewsMay 12, 2026

Knit Health Raises $11.6M for 'Fundamentally Different' Approach to Healthcare AI

Knit Health, a UC Berkeley spin‑out, announced a $11.6 million Series A round to commercialize its AI platform that emulates physician reasoning for operational tasks. The funding, led by XYZ Ventures with participation from HealthTech Capital, will accelerate product development and go‑to‑market efforts....

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New Home for Novo's Parkinson's Cell Therapy; GSK's Deal to Sell Drug in China
NewsMay 11, 2026

New Home for Novo's Parkinson's Cell Therapy; GSK's Deal to Sell Drug in China

Novo Nordisk has transferred its early‑stage Parkinson's disease cell therapy to a specialized biotech partner, allowing the pharma giant to offload development risk while retaining royalty rights. GSK secured a distribution agreement to launch its flagship drug in China, opening...

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Inhibrx Says Combo Therapy Shrank More Tumors than Merck's Keytruda Alone
NewsMay 11, 2026

Inhibrx Says Combo Therapy Shrank More Tumors than Merck's Keytruda Alone

San Diego‑based biotech Inhibrx reported that its experimental antibody INBRX‑106, when paired with Merck’s immunotherapy Keytruda, produced a higher rate of tumor shrinkage than Keytruda alone in patients with metastatic head and neck squamous cell carcinoma. The early‑stage study enrolled...

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Braveheart Bio's Hengrui-Licensed Cardiac Drug Scores Second Clinical Win
NewsMay 11, 2026

Braveheart Bio's Hengrui-Licensed Cardiac Drug Scores Second Clinical Win

Braveheart Bio announced that its heart‑muscle therapy, licensed from China’s Jiangsu Hengrui Pharmaceuticals, achieved its primary endpoint in a mid‑stage (Phase 2) trial for heart failure with reduced ejection fraction. The study reported an 8% absolute improvement in left‑ventricular ejection fraction...

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European Regulators Greenlight Fractyl Health's Clinical Test of GLP-1 Gene Therapy
NewsMay 11, 2026

European Regulators Greenlight Fractyl Health's Clinical Test of GLP-1 Gene Therapy

European regulators have granted Fractyl Health permission to begin the first human trial of a GLP‑1 gene‑therapy candidate. The Phase 1 study will test a single‑dose AAV‑based vector designed to produce continuous GLP‑1, aiming to replace daily injections for type 2 diabetes...

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Daiichi Sankyo Posts 'Extraordinary Loss' Of Nearly $1B
NewsMay 8, 2026

Daiichi Sankyo Posts 'Extraordinary Loss' Of Nearly $1B

Daiichi Sankyo announced it is scrapping its planned antibody‑drug‑conjugate (ADC) manufacturing line, a move that triggered an extraordinary loss of 149.4 billion Japanese yen (approximately $950 million). The loss reflects a write‑down of capital expenditures and R&D investments tied to the abandoned...

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FDA Delays Leqembi Decision; Artiva Raises $300M; Pharvaris Prices Offering
NewsMay 8, 2026

FDA Delays Leqembi Decision; Artiva Raises $300M; Pharvaris Prices Offering

The FDA has postponed its decision on the subcutaneous formulation of Leqembi, moving the target date to August 24, delaying a potential launch for Eisai and Biogen’s early‑Alzheimer’s therapy. The shift adds uncertainty to the Alzheimer market, where Leqembi could become...

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'Pharma, Not Really’: Top Young AI Talent Shuns Careers at Big Drugmakers
NewsMay 8, 2026

'Pharma, Not Really’: Top Young AI Talent Shuns Careers at Big Drugmakers

Top AI researchers like 33‑year‑old postdoctoral fellow Mazdak Abulnaga are increasingly turning away from legacy pharmaceutical companies. The article highlights a growing perception that big drugmakers are bureaucratic, data‑restricted, and slow to adopt cutting‑edge machine‑learning tools. In contrast, startups, academia,...

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Natalie Holles' Next Move After Third Harmonic Shutdown; Mark Alles Passes the Torch at ADC Biotech
NewsMay 8, 2026

Natalie Holles' Next Move After Third Harmonic Shutdown; Mark Alles Passes the Torch at ADC Biotech

Natalie Holles rebounded quickly after the shutdown of Third Harmonic, securing the chief executive role at Aura Biosciences. The transition was disclosed in a GlobeNewswire release on May 4, 2026, as the company moves toward enrollment completion for its Phase‑3 COMPASS trial....

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Capricor Sues Nippon Shinyaku over Duchenne Drug 'Pricing Flaw' And Launch Prep
NewsMay 8, 2026

Capricor Sues Nippon Shinyaku over Duchenne Drug 'Pricing Flaw' And Launch Prep

Capricorn Therapeutics has filed a lawsuit against Japan’s Nippon Shinyaku, alleging a breach of their licensing agreement for the Duchenne muscular dystrophy cell‑therapy candidate deramio‑cel. The complaint centers on a pricing flaw that Capricorn says Nippon Shinyaku misrepresented during launch...

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Odyssey Raises More than $300M as Biotech Goes Public
NewsMay 8, 2026

Odyssey Raises More than $300M as Biotech Goes Public

Odyssey Therapeutics completed a Nasdaq debut, raising $279 million by selling 15.5 million shares in its initial public offering. The biotech, focused on autoimmune‑disease therapeutics, priced the offering at $18 per share, above the $16.50 low end of its range. Proceeds will...

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Astellas Touts Data From Early Test of Stem Cell-Derived Eye Therapy
NewsMay 7, 2026

Astellas Touts Data From Early Test of Stem Cell-Derived Eye Therapy

Astellas Pharma announced early-stage data from its stem cell‑derived retinal therapy, aimed at treating age‑related macular degeneration (AMD). In a small cohort receiving the highest dose, patients showed statistically significant gains in best‑corrected visual acuity and no serious safety signals....

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Amazon Adds Ozempic Pill to Same-Day Prescription Drug Kiosks
NewsMay 7, 2026

Amazon Adds Ozempic Pill to Same-Day Prescription Drug Kiosks

Amazon Pharmacy is adding the GLP‑1 drug Ozempic to its same‑day prescription kiosks, which already dispense Wegovy. The vending‑machine‑style units allow customers to collect a prescription within minutes of approval, expanding Amazon’s instant‑pickup pharmacy footprint. By targeting a high‑demand weight‑loss...

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EnGene's Shares Crash on Updated Pivotal Bladder Cancer Data
NewsMay 7, 2026

EnGene's Shares Crash on Updated Pivotal Bladder Cancer Data

EnGene Therapeutics reported Phase 2 data for its experimental bladder‑cancer therapy that revealed a modest 5% objective response rate and safety signals in more than half of patients. The results triggered an 80% plunge in the Canadian biotech’s stock, wiping...

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Are Health Insurers Out of the Woods After a Tough 2025?
NewsMay 7, 2026

Are Health Insurers Out of the Woods After a Tough 2025?

Health insurers faced a challenging 2025, with many cutting or withdrawing profit forecasts amid rising claim costs, regulatory headwinds, and slower enrollment growth. In the first half of 2026, several carriers reported modest earnings rebounds driven by higher Medicare Advantage...

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Blackstone Puts $250M Into Anagram to Tackle Cystic Fibrosis Complication
NewsMay 7, 2026

Blackstone Puts $250M Into Anagram to Tackle Cystic Fibrosis Complication

Blackstone Life Sciences announced a $250 million investment in Anagram, a biotech developing a novel therapy for a cystic fibrosis complication. The capital, drawn from one of the industry’s largest private life‑science funds, will accelerate Anagram’s late‑stage clinical trials, manufacturing scale‑up,...

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Entrada Stock Falls on Duchenne Data; Wegovy Expands Access
NewsMay 7, 2026

Entrada Stock Falls on Duchenne Data; Wegovy Expands Access

Entrada Therapeutics reported topline results from its Duchenne muscular dystrophy (DMD) cohort of six patients, showing no meaningful functional improvement. The disappointing data sent Entrada's shares down roughly 15% in after‑hours trading. Meanwhile, Novo Nordisk announced expanded payer coverage for...

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Amgen Adds $300M to Puerto Rico Budget; Novartis to Exit Oral Drug Factory in Germany
NewsMay 7, 2026

Amgen Adds $300M to Puerto Rico Budget; Novartis to Exit Oral Drug Factory in Germany

Amgen announced an additional $300 million investment to expand its manufacturing footprint in Puerto Rico, bringing its total U.S. capital outlay to nearly $2 billion over the past year. The funding will support new bioprocessing lines and increase the island’s capacity for...

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Atara, Pierre Fabre's Cell Therapy to Get Another Shot at FDA Approval
NewsMay 7, 2026

Atara, Pierre Fabre's Cell Therapy to Get Another Shot at FDA Approval

Atara Biotherapeutics and Pierre Fabre Pharmaceuticals are reviving a T‑cell therapy that was rejected twice by the FDA. Regulators have signaled willingness to base a new approval decision on data from a Phase 3 trial, a departure from the earlier requirement...

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Pennsylvania Sues AI Chatbot Company for Posing as a Licensed Doctor
NewsMay 7, 2026

Pennsylvania Sues AI Chatbot Company for Posing as a Licensed Doctor

Pennsylvania has filed a lawsuit against Character.AI, accusing the startup of presenting an AI chatbot as a licensed physician in the state. The complaint alleges the bot offered medical advice, misrepresented its credentials, and violated state health‑care regulations. This marks...

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Angelini Fortifies Neurology Portfolio with $4.1B Buyout of Catalyst
NewsMay 7, 2026

Angelini Fortifies Neurology Portfolio with $4.1B Buyout of Catalyst

Italian drugmaker Angelini Pharma announced a $4.1 billion acquisition of U.S.-based Catalyst Pharmaceuticals, adding its trio of FDA‑approved treatments for rare neurological disorders to Angelini’s portfolio. The deal brings Ingrezza, Firdapse and a third specialty drug under Angelini’s control, instantly expanding...

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CellCentric Raises $220M to Get Multiple Myeloma Pill to Market
NewsMay 6, 2026

CellCentric Raises $220M to Get Multiple Myeloma Pill to Market

CellCentric, a 22‑year‑old transatlantic biotech, closed a $220 million Series D round to accelerate development of its oral multiple myeloma drug. The capital will fund the completion of Phase III trials, scale manufacturing, and prepare regulatory filings. The therapy is designed for patients...

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Bayer to Buy Perfuse Therapeutics for $300M Upfront
NewsMay 6, 2026

Bayer to Buy Perfuse Therapeutics for $300M Upfront

Bayer announced a $300 million upfront payment to acquire ophthalmology biotech Perfuse Therapeutics, securing its mid‑stage program aimed at the leading causes of blindness. The transaction represents Bayer’s first pharmaceutical merger‑and‑acquisition in several years, signaling a renewed focus on specialty eye...

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Novo Nordisk's Q1 in Four Words: Pills, Pricing, Payments and Pressure
NewsMay 6, 2026

Novo Nordisk's Q1 in Four Words: Pills, Pricing, Payments and Pressure

Novo Nordisk’s first‑quarter performance centered on its obesity drug Wegovy, which now serves roughly one million patients in the United States. The company is navigating heightened pricing pressure as insurers push for larger rebates while regulators scrutinize the drug’s cost....

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Pfizer's Albert Bourla Says He Has No Mega-Merger Plans
NewsMay 5, 2026

Pfizer's Albert Bourla Says He Has No Mega-Merger Plans

Pfizer CEO Albert Bourla told analysts on the company’s earnings call that a transformative merger or acquisition is not on the agenda. He emphasized that the firm will pursue growth through its existing vaccine, oncology and specialty drug pipelines. The...

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BioNTech to Scale Down Manufacturing, over 1,800 Jobs on the Line
NewsMay 5, 2026

BioNTech to Scale Down Manufacturing, over 1,800 Jobs on the Line

BioNTech announced in its Q1 2026 earnings release that it will shrink its mRNA‑vaccine manufacturing footprint, closing or consolidating several sites. The restructuring puts more than 1,800 jobs at risk, primarily in Germany and the United Kingdom. The company cited a...

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