The CEOs of all the leading Western developers of COVID-19 vaccines have vowed to only file for FDA approval after demonstrating safety and efficacy in phase 3. | The CEOs of all the leading Western...

Michael Becker, the former biotech CEO who spent his life working on new drugs and then turned to raising awareness of the cancer that would eventually kill him, has died of head and neck cancer th |...

With filings under way in Europe, Brazil, and a trio of Southeast Asian nations, Takeda unveiled long-term data for its dengue vaccine, showing the shot’s efficacy waned over time but that it was s |...

Eli Lilly says an investigational gene therapy has restored hearing in one child who has experienced hearing loss since birth. | Eli Lilly says an investigational gene therapy has restored hearing in...

Ginkgo Bioworks has snared one of its biggest partners to date. | Ginkgo Bioworks has snared one of its biggest partners to date. The biology biotech will work with none other than Pfizer in a drug...

Johnson & Johnson is closing a nearly 200,000 square-foot R&D outpost in Brisbane, California, less than 18 months after it opened, according to multiple sources familiar with the decision. | Johnson...

Back in 2015, AstraZeneca bought a majority stake in blood cancer biotech Acerta for $4 billion. But over the weekend, it said that some early data for its drug acalabrutinib was falsified. | Back in...

Pharmas have a record $1 trillion to deploy on new biotech innovation deals. All they need is for the Federal Reserve to lower rates, according to a new report from Ernst & Young. | Pharmas have a...

Ginkgo Bioworks doesn’t want the biotech industry’s therapies. | Ginkgo Bioworks doesn’t want the biotech industry’s therapies. But it does want the platforms that create them, which is why the cell...

Pfizer has already seen major success with its BioNTech-partnered COVID-19 vaccine, but, now, the Big Pharma is hoping to add to the arsenal with a pandemic pill using old antivir | Pfizer has...

Bayer has struck | Bayer has struck a deal to acquire Asklepios BioPharmaceutical for $2 billion upfront. The deal, which features an additional $2 billion in milestones, will give Bayer control of...

Frequency Therapeutics’ hearing loss treatment showed early signs of efficacy last year, with some patients showing improvements after a few months. | Frequency Therapeutics’ hearing loss treatment...

When it comes to antibiotic-resistant bacteria, so-called Gram-negative bugs are the most worrisome to scientists and drug developers. | Scientists at Genentech have perfected a naturally occurring...

The 20th century was the century of technology. The 21st century, meanwhile, has been heralded by geneticists Craig Venter, Ph.D., and Daniel Cohen, M.D., Ph.D., as the century of biology. Those with...

Novartis is adding another weapon to its arsenal of oncology therapies,

Ginkgo Bioworks and Boehringer Ingelheim are linking arms as they venture into the forest of undruggable targets, with the larger pharma offering up to $406 million for Ginkgo’s molecules. 

Saudi Arabia has launched a national biotech strategy in an effort to become an international biotech hub within the next 16 years. | Saudi Arabia has launched a national biotech strategy in an...

The Novo Nordisk Foundation, Wellcome and the Bill & Melinda Gates Foundation have inked a

Pfizer and German mRNA biotech partner BioNTech have released an early look at their experimental pandemic vaccine, and the news is good. | Pfizer and German mRNA biotech partner BioNTech have...

The FDA's Peter Marks, M.D., Ph.D., thinks gene editing—specifically base editing—could be a "game changer," but progress has been slow, likely due to discouragement with the regulatory p | The...

For decades, the FDA has been offering accelerated approvals to open early access to new cancer drugs, but mostly for patients who’ve already tried several other regimens. | For decades, the FDA has...

Accelerated approval—controversial, yes—but absolutely necessary for small, pre-revenue biotechs trying to find new treatments for small patient populations. | Accelerated approval—controversial,...

After a successful data hit at the start of spring, a new chief medical officer and a jump in stock price, Humanigen is starting the summer with the U.K.'s drug regulator acceptin | After a success...

Bayer has early evidence that its P | Bayer has early evidence that its Parkinson’s disease cell therapy is safe. Now, with a phase 2 clinical trial on course to open enrollment next year, the German...

CRISPR Therapeutics laid off a number of employees a week after FDA advisers all but greenlighted the company’s Vertex-partnered, CRISPR-edited sickle cell therapy, sources told Fierce Biotech.&nbs |...

Amgen’s KRAS inhibitor made a splash at this year’s American Society of Clinical Oncology (ASCO) annual meeting, and with good reason—it was the first drug of its class to post clinical data. | Two...

Boehringer Ingelheim is making yet

Three people with autoimmune diseases have responded positively to allogeneic CAR-T therapy, marking a first for the "off-the-shelf" cell therapy tech. | In a first, three patients with autoimmune...

Mikael Dolsten, M.D., Ph.D., Pfizer’s chief scientific officer and president for worldwide R&D and medical, is clear: The company's COVID-19 vaccine is here because of a decad | Mikael Dolsten, M.D.,...

It’s a common refrain in dementia studies: “We should have treated them earlier.” It’s why treating neurodegenerative diseases has been so difficult, Gerhard Koenig, Ph.D., told FierceBiotech.  |...

Just in time for the holiday season, Arvinas’ lead protein degraders

We take protecting anonymous sources around here seriously. You’ll rarely see us use them—we always prefer and push for on-the-record comments—so when we do, you know the subject is important. | We...

Johnson & Johnson’s $6.5 billion autoimmune drug has

GSK is paying 400 million euros ($430 million) upfront for fu | GSK is paying 400 million euros upfront for full rights to CureVac’s mRNA vaccines against influenza and COVID-19. The mRNA specialist...

Eli Lilly’s Alzheimer’s disease treatment sailed through an FDA advisory committee meeting Monday, with panelists praising the therapy as innovative—while also cautioning about a lack of data on sp |...

While Sanofi is looking to move more of its R&D in-house, there is still room for deals, and today it’s

Editas Medicine has confirmed that a cell therapy for sickle cell disease has successfully engrafted into the first patient dosed in a phase 1/2 trial, which means—for those of us without a science |...

After spinning out two companies at the start of the year, Sosei Heptares has now inked a new deal with Roche biologics unit Genentech. | After spinning out two companies at the start of the year,...

Sanofi and BioNTech’s vision of using mRNA to prime anti-cancer immune attacks has failed to hold up to clinical scrutiny. | Sanofi and BioNTech’s vision of using mRNA to prime anti-cancer immune...

It’s been six months since Johnson & Johnson’s overhaul of its infectious disease and vaccine units went into effect, and it appears that cuts to the portfolio have yet to stop. | Johnson & Johnson's...

Belharra Therapeutics is finally ready to rise out of stealth with $130 million in capital and Genentech caught up in the wave with a multiple-year collaboration. | Belharra Therapeutics is finally...

Roche has removed eight phase 1 and 2 oncology and neurology candidates from its pipeline as part of a set of “trade-offs” intended to “increase the overall portfolio value and speed up development |...

Novartis’ triple combination asthma candidate QVM149 has

GLP-1 agonists and their next-gen successors may still be center stage in the red-hot obesity space, but newly launched Syntis Bio is taking a different approach. | GLP-1 agonists and their next-gen...

Arch Venture Partners has raised | Arch Venture Partners has raised $1.5 billion to place another round of bets on early-stage biotechs. The VC shop, which lists Alnylam and Juno among its previous...

Patients with difficult cancers have seen a massive influx of new treatment options and hope for prolonged survival in recent years��except for those with the aggressive b | Inovio is hoping to change...

Five months after setting out a controversial new vision for the company, Sanofi's executives have begun informing employees who will be losing their jobs as a result, Fierce Biotech has learn |...

Eli Lilly is teaming up with OpenAI on a quest to develop new treatments that overcome antimicrobial resistance (AMR).   | Eli Lilly is teaming up with OpenAI on a quest to develop new treatments...

AstraZeneca has teamed up with MiNA Therapeutics to t | AstraZeneca has teamed up with MiNA Therapeutics to test small activating RNA (saRNA) molecules in metabolic diseases. The agreement gives...

After a year in the shadows, Prime Medicine is

Genentech has signed a multiyear contract to pan the diverse bacteria living in the digestive tract for biomarker signatures of drug response, new live bacterial therapeutics and novel targets for |...

Pfizer is continuing to pinball between oral obesity assets. | Pfizer is continuing to pinball between oral obesity assets. Months after making twice-daily danuglipron its top prospect, the Big...

Steven Kafka, the former Foundation Medicine chief operating officer who landed at Third Rock Ventures after a globetrotting “gap year,” has a new gig: CEO of Thrive Earlier Detection, a liquid bio |...

Pfizer is rushing to get its respiratory syncytial virus (RSV) vaccine

Pfizer and its partner BioNTech have five potential COVID-19 vaccines in clinical trials, each of which is based on a different mRNA format. | Pfizer and its partner BioNTech said Wednesday that...

It’s been a tough year for biotech, so how about a little good news? In between all the layoffs, restructurings and last-ditch strategic option hunting, we wanted to take a moment to shine a spotli...

An FDA advisory committee has voted against approving Merck & Co.’s gefapixant, a P2X3 receptor antagonist medicine designed to treat a | An FDA advisory committee has voted against approving Merck &...

Humanigen is prepping its COVID-19 drug lenzilumab for an emergency use authorization with the FDA before the month’s end. | Humanigen is prepping its COVID-19 drug lenzilumab for an emergency use...

In a historic day for cancer treatment and the larger biopharma industry, Novartis notched an FDA approval for its CAR-T treat | In a historic day for cancer treatment and the larger biopharma...

Having some free time following the $10.8 billion buyout of Prometheus Biosciences made Mark McKenna realize he had some “unfinished business.” | A brand-new biotech called Mirador Therapeutics has...

Novartis wants to give a $3.2 billion lift to its kidney disease pipeline. | Novartis wants to give a $3.2 billion lift to its kidney disease pipeline. While working to generate phase 3 data on its...

Antisense oligonucleotides (ASOs), which bind to RNA and prevent them from being translated into proteins, have gained popularity in recent years as a way to treat neurodegenerative diseases. |...

Against a backdrop of a tough funding environment, nearly half (48%) of biotechs are using partnerships with Big Pharmas as a financing method, according to a survey commissioned by CRO Icon.< |...

At long last, Editas Medicine has made it. | Though Editas and Allergan are not the first companies to test a CRISPR-based medicine in humans—that distinction goes to CRISPR Therapeutics and Vertex...

Over the years, more and more patients with cystic fibrosis have benefited from new drugs such as Vertex’s Trikafta. | Over the years, more and more patients with cystic fibrosis have benefited from...

As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-re |...

Antibodies and other protein therapeutics can treat a wide range of diseases, but they come with various challenges that have limited their reach.  | Antibodies and other protein therapeutics can...

If there’s anything this pandemic has taught us, it's that biotech—and its investors—will not be stopped. | If there’s anything this pandemic has taught us, it's that biotech—and its investors—will...

Twenty-five years after launching, Genmab co-founder and CEO Jan van de Winkel, Ph.D., has earned himself the right to briefly bask in the company’s success.  | Genmab, coming off one of its most...

Genentech will close its cancer immunology research department, and unit head and renowned cell biologist Ira Mellman, who has been with the company for 17 years, will depart in the coming months.< |...

Roger Perlmutter, M.D., Ph.D., has taken up the CEO post at Eikon Therapeutics. | Roger Perlmutter has taken up the CEO post at Eikon Therapeutics. The startup disclosed the hiring of the former...

mRNA technology is making waves with the success of the COVID-19 vaccines by Pfizer-BioNTech and Moderna. | A University of Pennsylvania team of renowned scientists in mRNA and T-cell immunotherapy...

Eli Lilly has held the grand reveal of the Alzheimer’s disease trial data it hopes will secure FDA approval for donanemab by the end of the year. | Eli Lilly has held the grand reveal of the Alzhei...

CAR-T has seen a host of successes in blood cancers, but translating that into solid tumors has proven much more difficult. | CAR-T has seen a host of successes in blood cancers, but translating that...

Apparently, C4 Therapeutics' protein degradation tech brings all the Mercks to the yard. | Apparently C4 Therapeutics' protein degradation tech brings all the Mercks to the yard. The Massachusetts...

The Association of Clinical Research Organizations (ACRO) has asked the FDA to update its official guidelines to help CROs and other sponsors make better use of new tech and sharing platforms in cl |...

  | Takeda cemented itself as a player in the immunology arena when it bought Nimbus' TYK2 inhibitor a year ago, putting it toe-to-toe against Bristol Myers Squibb. Now, the Japanese pharma has...

Pass the mead, because Viking Therapeutics has plenty to celebrate after its dual agonist of GLP-1 and GIP was 

The gene editing system CRISPR-Cas9 has generated excitement for its potential use in eliminating disease-causing irregularities in DNA. | CRISPR-Cas9 has generated excitement for its potential use...

The idea to build a company around degrader-antibody conjugates (DACs)—not to be confused with antibody-drug conjugates (ADCs)—has been bubbling for a while. | The idea to build a company around...

Psychedelic drugs like LSD have long been of interest in the medical community because of their anti-inflammatory properties. | A team of researchers at Eleusis discovered that structural character...

As it gears up to move its lead cell therapy into phase 3, Regenerex has closed a $100 million financing, built out its leadership team and renamed itself Talaris Therapeutics after the winged sand |...

Multiple companies aim to surmount the limitations of CAR-T therapy by going beyond T cells and engineering cell therapies based on natural killer (NK) cells or macrophages instead. | Multiple...

The NIH’s National Center for Advancing Translational Sciences is teaming up with StemoniX to use its brain-on-a-chip platform to test new treatments for pain, opioid misuse and addiction.  | The...

Sanofi’s $3.7 billion Principia Biopharma buyout has delivered a phase 3 victory. | Sanofi’s $3.7 billion Principia Biopharma buyout has delivered a phase 3 victory. The BTK inhibitor moved the...

Chroma Medicine thinks it can silence and activate genes via epigenetic editing, and the biotech uncovered itself with

After dribs and drabs surfacing about Gilead Sciences' COVID-19 hopeful, remdesivir, the first data from a placebo-controlled study are here—at least, an early look at them. | After dribs and drabs...