Avalyn Plots IPO to Push Inhaled Pulmonary Fibrosis Pipeline Through Clinic
Avalyn Pharma announced its intent to launch an IPO on Nasdaq under the ticker AVLN, though the number of shares and target raise remain undisclosed. The company will channel the proceeds into advancing its inhaled pulmonary‑fibrosis pipeline, beginning with AP01, an inhalable pirfenidone formulation slated for Phase 2b trials. Additional candidates include AP02, a nintedanib‑based tyrosine‑kinase inhibitor moving toward Phase 3, and AP03, a fixed‑dose combo of AP01 and AP02 headed for Phase 1. Avalyn’s move comes as biopharma IPOs remain scarce but strategically vital for funding late‑stage assets.
Innovent’s CDMO Gets Green Light to Make Biologics at Large Chinese Plant
Innovent Biologics’ CDMO, Altruist Biologics, received its first 20,000‑liter biologics production license from China’s NMPA for the Hangzhou plant, marking the country’s inaugural facility of this scale. The site, equipped with four 20,000‑liter bioreactors, will be expanded to 172,000 liters, complementing...
Automation, Collaboration and the Future of Advanced Therapies
BioSpace’s Denatured podcast episode explores how soaring demand for cell and gene therapies is driving the industry toward automation, digitization, and robotics. Guests Jason Jones of Cellular Origins and Alexander Seyf of Autolomous discuss the need for scalable, sterile manufacturing workflows...
Gilead Less M&A Happy Now but Door Still Open for ‘Compelling’ Opportunities
Gilead Sciences announced a third 2026 acquisition, buying German ADC specialist Tubulis for $5 billion, bringing its total spend on three deals this year to $14.77 billion. The spree began with a $7.59 billion purchase of CAR‑T partner Arcellx and a $2.18 billion deal...
Insmed Scraps Skin Plans for Lung Disease Drug as Competitors Make Headway
Insmed announced it will drop development of its lung‑disease drug Brinsupri for hidradenitis suppurativa after the Phase 2b CEDAR trial showed no efficacy, with placebo outperforming both tested doses. The study also missed secondary endpoints, prompting the company to cease the...
Lilly’s Foundayo Nod Launches New Battle With Novo, M&A Mania Continues, Tariffs Hit Pharma
Eli Lilly received FDA approval for its oral obesity drug Foundayo (orforglipron), sparking a direct rivalry with Novo Nordisk’s Wegovy pill, which posted a modest efficacy edge in Phase 3 trials. The drug’s convenience—no water required—could differentiate it in a crowded market. Meanwhile,...
When a Good Boss Is Bad for Your Career
The piece argues that not all good bosses drive career growth, separating “stretch leaders” who broaden scope and expose employees to senior‑level reasoning from “comfort leaders” who shield teams from politics but limit development. Stretch leaders build judgment, visibility, and...
As CGT Manufacturing Scales Up, Automation and Collaboration Become Essential
Cell and gene therapy manufacturing faces a scalability crunch as single batches cost over $500,000 and skilled labor shortages drive high turnover. Companies are turning to robotics, AI, and digital dashboards to automate processes, cut contamination risk, and harness real‑time...
Daré's CEO Wants Everyone To Invest in Women’s Health, Starting With Her Company
Daré Bioscience, led by CEO Sabrina Martucci Johnson, launched a Regulation A offering to raise $24.3 million, allowing individuals to invest as little as $250. The biotech focuses exclusively on women’s‑health therapeutics, including menopause, fertility, and vaginal‑health products, with its first solo...
AbbVie Puts Humira on TrumpRx at Steep Discount as Tariff Threat Solidifies
AbbVie has agreed to sell its blockbuster arthritis drug Humira on the Trump administration’s direct‑to‑consumer platform TrumpRx for about $950, an 86 % cut from the typical $6,900 out‑of‑pocket price. The deal, announced after AbbVie pledged $100 billion in R&D and manufacturing...
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
The FDA is requesting new legislative authority to enforce post‑approval manufacturing changes, including major facility or active pharmaceutical ingredient (API) supplier switches. The proposal, part of the FY 2027 budget, would amend the 1997 FD&C Act to require validation and approval...
FDA’s 2027 Budget Proposes Permanent Rare Disease Vouchers, Easier Entry to Clinic
President Trump’s FY 2027 budget proposes a $7.23 billion allocation for the FDA, a 3.2% increase over 2026, while the broader HHS budget shrinks by 12%. The agency plans to make the rare pediatric disease priority‑review voucher program permanent, averting an estimated...
Pharma Pipeline Stalls for First Time in Decades: Citeline
The Citeline Pharma R&D report shows the first decline in investigational drug candidates since the mid‑1990s, with the pipeline falling 3.92% to 22,940 assets at the start of 2026. While a methodological tweak may have softened the drop, the contraction...
AI Giant Anthropic Leans Into Life Sciences With $400M Coefficient Bio Catch
Anthropic is buying New York‑based biotech startup Coefficient Bio for an estimated $400 million, folding the stealth‑mode firm into its newly created Claude Life Sciences team. Coefficient’s founders bring machine‑learning experience from Roche’s Genentech, bolstering Anthropic’s push into drug‑discovery, clinical‑trial, and...
Takeda Breaks Up With Denali, Dumps Dementia Drug
Takeda Pharmaceutical has ended its eight‑year partnership with Denali Therapeutics, returning all rights to the frontotemporal dementia candidate DNL593. The split follows earlier termination of the joint Alzheimer’s program DNL919 and is attributed to strategic considerations rather than safety or...
FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls
In 2024 the FDA signaled support for using natural‑history external controls in rare‑disease gene‑therapy trials, but later reversed that stance for uniQure’s Huntington’s therapy, demanding a sham‑surgery Phase 3 study. The agency’s guidance still encourages innovative designs, yet recent reversals for...
Lean Derisking: Smart Ways to Cross Drug Development’s “Valley of Death”
API’s recent webinar highlighted practical strategies to bridge the drug‑development "valley of death," emphasizing early derisking from discovery through first‑in‑human studies. The panel stressed using AI‑driven in‑silico filters, staged in‑vitro and animal testing, and aligning preclinical models with clinical biomarkers...
BioNTech Starts Shuttering Singapore mRNA Manufacturing Site Amid Pipeline Pivot
BioNTech announced it will shut its Singapore mRNA manufacturing plant by the end of February 2027, ending a venture that began with a $355 million investment in 2022. The site, originally slated to create over 100 jobs and produce several hundred...
11 Startups Selected for National Life Sciences Accelerator Program
Eleven early‑stage life‑sciences startups were chosen for the Drive accelerator, with eight headquartered in Massachusetts and the remaining three in South Carolina. MassBio will manage the biotech cohort while SCbio leads the biomarkers and diagnostics group. The free eight‑week program...
Biopharma M&A Heats Up, Rare Diseases Win Three Approvals, Wave Crashes
Biopharma giants Biogen, Eli Lilly and Merck collectively spent over $20 billion in a single week to acquire biotech firms with approved products or promising pipelines, accounting for three of the year’s four largest deals. Merck bought Terns Pharmaceuticals for $6.7 billion, while...
Ambrosia Eyes Next-Generation Small Molecule GLP-1s With $100M Series B
Ambrosia Biosciences announced the completion of a $100 million Series B financing round to fund the development of next‑generation small‑molecule GLP‑1 oral therapies for obesity. The capital will support a Phase 1 trial of its lead GLP‑1 candidate, which leverages AI‑driven molecular design...
IO Shuts Down Following Regulatory Roadblocks
Danish biotech IO Biotech announced it will wind down operations and file for Chapter 7 bankruptcy after regulatory setbacks. The FDA rejected its biologics license application for the cancer vaccine Cylembio in September, citing insufficient data. A Phase 3 trial combining Cylembio...
3 Career Moves R&D Professionals Must Make in a Skills-Based, AI-Driven Economy
Biopharma R&D careers are shifting from title‑driven ladders to skills‑centric portfolios as AI automates routine tasks. Professionals must treat each role as an opportunity to acquire execution‑level capabilities, use generative AI to deepen scientific judgment, and continuously assess and market...
The Brave New World of Radiotherapeutics
Radiotherapeutics have moved from niche concepts to a burgeoning oncology platform, driven by unmet treatment gaps and the commercial breakthrough of Novartis' Pluvicto. Early data show Actinium‑225 delivering 45‑50% response rates in heavily pre‑treated prostate cancer, while Bayer's Xofigo adds...
After Missing Kezar Buyout in 2024, Tang Returns as CEO of Aurinia With $50M Offer
Kevin Tang, newly installed CEO of Aurinia Pharmaceuticals, has revived his bid for Kezar Life Sciences with a $50 million offer of $6.95 per share, roughly matching Kezar’s $47 million market cap. The proposal follows Tang’s earlier, unsuccessful $1.10‑per‑share attempt made through...
Takeda Restructuring Could Push More Than 600 US Staffers Out of Jobs
Takeda Pharmaceutical announced a U.S. restructuring that will affect roughly 634 employees, including 247 positions in its Cambridge, Massachusetts site. The plan aims to generate savings of over 200 billion yen (about $1.25 billion) by fiscal year 2028, funding upcoming product launches...
Kardigan Blood Pressure Drug Proves Hypothesis Despite Split Phase 2 Readout
Kardigan reported that its experimental hypertension drug tonlamarsen achieved a 67% average reduction in the angiotensinogen biomarker after five monthly doses, confirming target engagement. However, the Phase 2 trial showed no statistically significant difference in office systolic blood pressure between the...
Biogen Bounces Back With FDA Nod for High-Dose Spinal Muscular Atrophy Drug
The FDA approved a high‑dose formulation of Biogen’s SMA drug Spinraza, cutting the loading phase from four to two injections and adding a four‑month maintenance schedule. The new regimen, backed by the DEVOTE study, showed significant motor‑skill gains versus sham...
Webinar: Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises
A BioSpace webinar highlighted how biotech firms can close the expectation gap with the FDA to avoid last‑minute decision‑day setbacks. Speakers emphasized the FDA’s recent pledge—led by Commissioner Marty Makary and CBER Director Vinay Prasad—to provide regulatory navigation for small companies,...
Leadership, Not Managers, More Likely To Drive Employees Away, BioSpace Finds
A BioSpace survey of U.S. life‑science professionals shows 15% are looking for new jobs because they are unhappy with company leadership, compared with 9.1% citing dissatisfaction with their direct manager. Respect for CEOs remains flat at roughly 80%, while respect...
Beyond the Cornfields, Indiana’s Life Sciences Industry Grows Tall
Indiana’s life‑sciences sector is rapidly expanding, now encompassing over 3,300 companies that employ roughly 70,000 workers and generate a $102 billion economic impact. Flagship firms such as Eli Lilly are driving major investments, including a $13 billion Medicine Foundry slated to create 400...
UCB Investing $2B To Build Manufacturing Facility in Georgia
UCB announced a $2 billion investment to build a 460,000‑square‑foot biologics manufacturing plant in Gwinnett County, Georgia, its first U.S. production site. The facility will create about 330 permanent jobs and over 1,000 construction positions, leveraging AI, robotics and automation. Georgia...
11 Companies Hiring Now in New York
New York’s life‑sciences cluster, anchored by pharma giants such as AbbVie, Merck, Pfizer and a suite of top universities, is experiencing a hiring surge. BioSpace data show job postings in February rose 22% year‑over‑year and 13% month‑over‑month, with roughly 300 positions...
RA Capital Looks to China for Next Startup To Put on SPAC Track to Nasdaq
RA Capital Management has filed a prospectus for a new SPAC, Research Alliance III, with up to $57.5 million of capital. The blank‑check vehicle is openly scouting life‑science startups, emphasizing Chinese drug developers as potential targets. While the SPAC has not yet...
Gilead’s Ouro Buy, J&J/Protagonist’s Approval, Aurinia’s Revamp, ACIP Confusion, More
Gilead announced a $2.1 billion acquisition of Ouro Medicines and its T‑cell engager OM336, planning to split the deal with long‑time partner Galapagos. Johnson & Johnson and Protagonist Therapeutics secured FDA approval for Icotyde, an IL‑23 receptor blocker that becomes Protagonist’s...
Trace Unites ALS Teams Behind a Target That Could Broaden Treatment Access
Trace Neuroscience, launched Nov 2024, is developing an antisense drug, TRCN‑1023, to restore UNC13A protein function in ALS patients. The target emerged from parallel discoveries at UCL and Stanford, and the company plans intrathecal delivery and biomarker‑guided trials. Leveraging lessons...
Aardvark Pauses 2 Obesity Trials, Reveals New Details on Cardiac Concerns
Aardvark Therapeutics has paused two Phase 2 obesity trials, POWER and STRENGTH, after cardiac safety signals emerged in its lead compounds ARD‑101 and ARD‑201. The anomalies were observed in healthy volunteers receiving double the target dose, prompting a halt to the...
Gilead Chief Gets 20% Pay Bump, Still Falls Short of $30M Club
Gilead Sciences announced that CEO Daniel O’Day earned $28.44 million in 2025, a 20% increase from the prior year and 119 times the median employee salary. The compensation surge was driven largely by stock awards and incentives. In the same period,...
Japan's Drug Prices Are Creating Problems for Washington and Tokyo Alike
President Donald Trump and Japanese Prime Minister Sanae Takaichi discussed a $40 billion U.S. nuclear investment and pledged cooperation on drug‑pricing reform. Japan plans a 4% cut to total drug spending, further lowering reimbursements for new medicines. The article warns that...
Tang Seizes Control of Aurinia, Taking CEO Post in Total Transformation of C-Suite
Kevin Tang, chair of Aurinia’s board and head of Tang Capital Management, has seized the CEO role, replacing Peter Greenleaf, and installed fellow Tang Capital executives as COO, CFO, and CSO. Tang Capital expanded its ownership from 5.1% in September 2024 to 9.2%...
Validated Mechanisms, Strong Data Beat Hype in Longevity Investing
Longevity investing has shifted from hype to data‑driven strategies, according to LongeVC partners Sergey Jakimov and Artem Trotsyuk. They argue that startups must focus on measurable, disease‑specific mechanisms rather than treating aging as a single target, aligning with FDA and...
Powering the Next Wave of Cell Therapy: From iPSC-Derived Cells to In Vivo Reprogramming
Induced pluripotent stem cells (iPSCs) are being engineered into diverse therapeutic cell types, while in vivo reprogramming aims to convert resident cells directly within patients, eliminating traditional cell‑manufacturing steps. Both strategies depend on precise recombinant growth factors, cytokines, extracellular matrix proteins...
Gene Therapies for Hearing Loss Strike an Encouraging Note in Embattled Modality
Gene‑therapy candidates for hereditary hearing loss are gaining traction as safety concerns ease with localized delivery. Regeneron’s DB‑OTO and Eli Lilly’s AK‑OTOF have each demonstrated clinically meaningful hearing improvements in early‑stage trials, positioning them as frontrunners for the first approved deafness...
9 Months In, FDA’s New Priority Voucher Program Still Clouded With Uncertainty
The FDA’s National Priority Voucher (CNPV) program, launched in June 2025, promises to cut drug review times from 10‑12 months to just one or two months for products that meet defined national priorities. Early successes include Johnson & Johnson’s Tecvayli/Darzalex...
Biopharma Could Provide a Haven for Investment as Middle East Conflict Roils Global Markets
Analysts at Truist Securities argue that biopharma has acted as a defensive haven during recent geopolitical turmoil, outperforming the broader S&P 500. Their review of the past six years shows the Health Care Select Sector ETF (XLV) delivering steadier returns and...
Sarepta Plans FDA Run for Duchenne Exon Skippers Despite Confirmatory Trial Failure
Sarepta Therapeutics will submit a supplemental NDA to the FDA seeking to convert the accelerated approvals of its Duchenne exon‑skippers Amondys 45 and Vyondys 53 into traditional approvals, despite the confirmatory ESSENCE trial failing to improve motor function. The company bolsters its...
Gossamer Nearly Halves Workforce in Savings Push After Late-Stage Hypertension Fail
Gossamer Bio announced a near‑half workforce reduction after its Phase 3 seralutinib trial failed to meet statistical significance in pulmonary arterial hypertension. The company will lay off 77 employees, about 48 % of staff, aiming to preserve cash while its future path...
TerraPower Commits $450M to Build Radioisotope Production Plant
TerraPower Isotopes is committing $450 million to build a cGMP‑compliant actinium‑225 manufacturing plant in Philadelphia, a move that will expand production capacity roughly twenty‑fold. The 250,000‑square‑foot facility, slated to begin output in 2029, will create 225 full‑time jobs and benefits from...
Protagonist’s First Approval Spells Trouble for Pharma’s Immunology Heavyweights
Protagonist Therapeutics received FDA approval for icotrokinra, marketed as Icotyde, becoming the first oral IL‑23 receptor blocker for plaque psoriasis. The clearance arrived ahead of schedule, unlocking a $50 million milestone from Johnson & Johnson and setting up royalty terms of 6‑10% on...
Kennedy’s Vaccine Agenda Stalled, Structure’s ‘Competitive’ Obesity Pill, Novo’s Warning Letter
Structure Therapeutics reported a 16.3% weight loss after 44 weeks in a Phase 2 trial of its oral GLP‑1 pill, positioning it as a competitive alternative to Eli Lilly’s and Novo Nordisk’s candidates. Rhythm Pharmaceuticals disclosed that its obesity drug Imcivree failed in...