BMS reports data that could give its cell therapy an edge over rival J&J product

Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving the FDA-approved CAR T-cell therapy into an earlier line of treatment—ahead of a rival cell therapy. In other BMS cell therapy news, the pharma giant started an R&D alliance focused …

BMS reports data that could give its cell therapy an edge over rival J&J product Read More »

New Versant Ventures startup goes ‘gutless’ for next-generation gene delivery

Vector BioPharma has launched from the biotech startup incubator of Versant Ventures, which is backing the company with a $30 million Series A financing. Vector is developing virus-like particles with the capability to deliver large payloads of genetic medicines to a wide range of tissues.

Merck turns to biotech Cerevance to feed neuro pipeline with Alzheimer’s drugs

Merck is paying $25 million to kick off a research partnership with Cerevance, a startup that analyzes donor brain tissue to find novel targets for new neurological disorder drugs. While Cerevance’s lead program is a Parkinson’s disease drug, Merck is wants to see if the startup’s technology can help it discover and develop new Alzheimer’s …

Merck turns to biotech Cerevance to feed neuro pipeline with Alzheimer’s drugs Read More »

GSK pays $100M to partner on a cancer drug with new twist on immunotherapy

GSK is partnering with Mersana Therapeutics on the development of an antibody-drug conjugate that is approaching Phase 1 testing. Unlike other ADCs that deliver a toxic drug payload, the Mersana drug is designed to activate the innate immune system to fight tumor cells.

Pfizer to buy sickle cell disease biotech Global Blood Therapeutics in $5.4B deal

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.

FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.

Traditional approaches to growth in biopharma are no longer sustainable

Over the past 15 years, more than 60% of asset growth among the top 30 biopharma companies came from acquisitions. Such inorganic growth is no longer viable, argues Pervaise Khan, Accenture’s UK Life Sciences Lead. The pace of innovation in biopharma has rocketed over the last two years, with vaccines, new antivirals, and therapies delivered …

Traditional approaches to growth in biopharma are no longer sustainable Read More »

Amgen’s $3.7B ChemoCentryx acquisition adds a new piece to autoimmune strategy

Amgen’s drug portfolio boasts several biologic drugs that are blockbuster sellers. In acquiring ChemoCentryx for $3.7 billion, the pharmaceutical giant gains a company entirely focused on developing small molecule alternatives to biologic medicines.

Alnylam drug succeeds in heart study, setting stage for FDA filing and showdown with Pfizer

Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease. An FDA submission is planned, which would pit the Alnylam drug in competition with a blockbuster …

Alnylam drug succeeds in heart study, setting stage for FDA filing and showdown with Pfizer Read More »

Ipsen’s latest R&D alliance brings novel T cell-activating drugs for cancer

Ipsen has been an active dealmaker lately, and it just struck another one that takes the pharmaceutical company into a new area of drug research. The Paris-based company is collaborating with Marengo Therapeutics on the development of two drugs that selectively activate T cells to fight cancer.

Aiming to bring drug combos into earlier lines of cancer therapy, IDRx lands $122M

Taking inspiration from the success of drug cocktails that halt viral infections, startup IDRx aims to develop cancer drug combinations that stop tumor escape. The company, founded by serial entrepreneur Alexis Borisy, has set gastrointestinal stromal tumor (GIST) as its first disease target.

With ‘bold experiment’ in drug pricing, Arcutis aims to stand out in plaque psoriasis

The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it believes will speed up insurance coverage and patient adoption of the new treatment for the chronic inflammatory skin disorder.

FDA hits pause on Beam Therapeutics’ off-the-shelf cell therapy for blood cancers

Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical hold news, the FDA lifted a hold on a Celyad Oncology cell therapy clinical trial that was halted in March.

Novartis, UC Berkeley-spawned startup snags $65M to keep key proteins out of the cell’s trash can

Vicinitas Therapeutics is developing small molecule drugs that stabilize key proteins, preventing them from going to a cell’s built-in disposal system. The startup, which stems from a research partnership between Novartis and the University of California, Berkeley, has raised $65 million in Series A funding.

U.S. government places $1.74B order for Moderna’s new Covid-19 vaccine boosters

The U.S. government has signed a supply agreement securing 66 million doses of Moderna’s Covid-19 vaccine booster shots, which are designed to address the omicron subvariants driving new cases of infection. The agreement follows a similar supply agreement reached with Pfizer and BioNTech.

Don’t miss the MedCity INVEST PharmaTech virtual conference July 26

The conference highlights the convergence of digital health and drug development. Among the panel discussions are a focus on the state of AI in drug discovery and the future of digital medicines. A startup pitch contest spotlights companies seeking to improve clinical trials. Register for free today!

Novartis turns to algorithms developer Anumana to apply AI to cardio conditions

Novartis is partnering with algorithms startup Anumana to develop a new artificial intelligence-based solution for cardiovascular diseases. The goal is to find ways to detect heart conditions years before symptoms develop in order to enable earlier intervention.

Harvard spinout lands $40M to bring in vivo drug discovery to cancer

Technological advances are moving drug discovery work to computers, but experimental medicines still must be tested in animals. Startup Manifold Bio is developing technology that enables the testing of hundreds of molecules in a single mouse, bringing drug hunters valuable in vivo data much earlier in the drug discovery process.

FDA delay means BeiGene, Novartis must wait longer for cancer drug decision

The FDA has deferred a regulatory decision on an esophageal cancer drug from partners BeiGene and Novartis, citing the need to complete inspections of the China-based facilities where the drug is made. The agency said Covid-19 travel restrictions have prevented it from conducting those inspections.

Merck strikes a $290M deal for novel prostate cancer drug

Merck is partnering with Orion on the clinical development and potential commercialization of a new drug for advanced prostate cancer. Though Merck already has a piece of the prostate cancer drug market, Orion’s drug would offer a new approach for treating cancers that have become resistant to currently available hormone therapies.

Neuro startups form latest group of grads from PharmStars digital health accelerator

PharmStars, a digital health accelerator, graduated its latest cohort of startups, each of them developing a solution addressing some aspect of neurological disease. The accelerator is accepting applications for the next group of startups for the fall program. The theme is innovations in real-world evidence.

Areteia gets $350M to turn failed ALS drug into a therapy for severe asthma

New company Areteia Therapeutics launched with up to $350 million in financing and an asthma drug candidate from Knopp Biosciences. That drug, dexpramipexole, previously failed a pivotal test in amyotrophic lateral sclerosis but more recent clinical testing found that the way the small molecule works has applications in eosinophilic asthma, a severe form of the …

Areteia gets $350M to turn failed ALS drug into a therapy for severe asthma Read More »

What to Know About Gene Therapy

Gene therapy is making a world where cancer and AIDS can be cured, and a person can alter their genetic makeup, changing the direction of their own and their offspring’s evolution in the process. However, the effects of gene therapy are long-lasting, and may impact both your and the health of your future children.  What …

What to Know About Gene Therapy Read More »

Roche pays $55M for late-stage drug for rare kidney disease with no approved treatment

An Ionis Pharmaceuticals drug has positive Phase 2 results in immunoglobulin A nephropathy, leading Roche to exercise its option to license the rights to the molecule. The pharmaceutical giant gets a contender in the chase to win the first regulatory approval of a therapy for this rare kidney disease.

Vertex builds up pipeline of type 1 diabetes cell therapies with $320M buyout

Vertex Pharmaceuticals already has a cell therapy candidate for type 1 diabetes but the company says acquiring rival ViaCyte will provide it with complementary assets and technologies. The two companies already share a partner in common: both have therapeutic candidates that use the gene-editing capabilities of CRISPR Therapeutics.

Pfizer, BioNTech Covid-19 vaccine gets full FDA approval for adolescents

The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers for an antiviral and Novavax’s European marketing authorization has been expanded to an additional age group.

AbbVie & Alector drop Alzheimer’s med from alliance, shifting focus to a 2nd drug

AbbVie paid Alector $205 million up front five years ago to begin an R&D partnership on two drugs intended to bring an immunotherapy approach to the treatment of Alzheimer’s disease. One of the drugs has reached Phase 2 testing but the pharmaceutical giant has terminated the alliance on a program in Phase 1.

Amgen joins Kernal Bio’s $25M financing as the startup brings mRNA 2.0 to cancer

Kernal Biologics has technology that enables the delivery of messenger RNA therapies to a wider range of destinations in the body. The Series A financing comes as the startup works to advance its lead immuno-oncology program toward its first clinical test.

After initial failure, Intercept Pharma feels new data can get NASH drug approval

Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.

With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

CureVac sues BioNTech, claiming Covid-19 vaccine infringes key mRNA patents

Messenger RNA vaccine biotech CureVac is suing BioNTech, alleging that its rival’s Covid-19 vaccine infringes on intellectual property built on more than two decades of research. BioNTech responded that its work is original and the company will defend against the infringement allegations.

AstraZeneca broadens its scope in blood cancers with $100M TeneoTwo buyout

AstraZeneca is acquiring TeneoTwo in a $100 million bet on that biotech’s lymphoma drug candidate, which is designed to go after two targets. It’s the latest deal made by a big pharmaceutical company looking to get its hands on a new type of cancer therapy called a T cell engager.

Novartis pays $100M to get Mallinckrodt’s ticket for a speedier FDA drug review

Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for these vouchers, which grant a company a shorter regulatory review timeline for a drug that addresses a rare or neglected disease.

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

How Can Biopharma Companies Sustain Growth & Innovation?

What You Should Know: – The traditional approach to fostering biopharma growth is no longer sustainable, according to Accenture research and analysis. The new research reveals perspectives on the life sciences industry based on an extensive analysis of over 300 M&A deals made by the top 30 biopharma companies between 2010–2021. – The analysis reveals multiple factors are eroding the sustainability of an inorganic growth strategy, such as rising costs of M&A, declining ability to pay and new challengers. However, …

How Can Biopharma Companies Sustain Growth & Innovation? Read More »

Feds commit $3.2B to lock in Covid-19 vax supply ahead of fall vaccination campaign

New Covid-19 vaccine booster shots are coming and they’ll likely include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall.

Bayer, Amgen join $120M financing for startup aiming to expand genetic meds delivery

In less than one year, ReCode Therapeutics has reeled in $200 million in financing. Big pharmaceutical companies are taking notice of the biotech startup’s technology, which enables lipid nanoparticles to go a wide range of organs and tissues, potentially broadening the reach of genetic medicines.

Merck Digital Sciences Studio Launches to Support Biomedical Startups

What You Should Know: – Merck, today announced the launch of the Merck Digital Sciences Studio (MDSS) to enable the generation of innovative technologies for drug discovery and development. – MDSS will support early-stage biomedical startups with direct investment, access to powerful Azure Cloud computing and opportunities to pilot their technologies in collaboration with discovery …

Merck Digital Sciences Studio Launches to Support Biomedical Startups Read More »

Two for two: Sanofi snares twin European nods for enzyme replacement therapies

Sanofi won European Commission approval for two therapies that treat rare enzyme deficiencies. Xenpoyzme is the first treatment for acid sphingomyelinase deficiency (ASMD) while Nexviadyme is a successor to a blockbuster Sanofi drug for Pompe disease.

BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy

The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.

Ipsen’s $247M Epizyme acquisition brings approved cancer drug & more in pipeline

Ipsen is paying $247 million to acquire Epizyme, a cancer drug developer with one FDA-approved product: follicular lymphoma therapy Tazverik. The drug is a modest seller now, but more cash could be paid out if the small molecule hits sales targets in coming years.

As muscular dystrophy drug meets key goal, Italfarmaco plans march forward to regulators

A Duchenne muscular dystrophy drug candidate from Italfarmaco Group has encouraging preliminary data from a pivotal study. The Milan, Italy-based pharmaceutical company says it now plans to meet with U.S. and European authorities about seeking regulatory approval for the small molecule.

New data for Intellia’s CRISPR therapy shows potential for one-time treatment of a rare disease

An Intellia Therapeutics therapy that uses CRISPR to perform in vivo genomic edits has clinical data showing that the therapeutic effects continue for a year in patients. The biotech now plans to speak with regulators about the design for a pivotal clinical trial testing this therapy, a potential one-time treatment for a rare inherited disease.

Biopharma firm Radius Health is going private in an $890M M&A deal

Two private equity firms have reached an $890 million deal to buy Radius Health, a company whose main asset is the commercialized osteoporosis drug Tymlos. In other M&A news, cancer biotech F-star Therapeutics is being acquired in a $161 million deal.

Which clinical trial innovation startups will present at INVEST PharmaTech Pitch Perfect?

The Pitch Perfect contest at MedCity INVEST PharmaTech, the free virtual conference scheduled for July 26, will spotlight five startups seeking to improve clinical trials.

Novartis picks Precision Bio to bring in vivo gene editing meds to blood disorders

Novartis is paying Precision Bio $75 million up front to begin a partnership aiming to develop in vivo gene-editing therapies for serious genetic blood disorders, such as sickle cell disease. One of the goals of the alliance is to make genetic medicines more globally accessible.

Athira Alzheimer’s drug fails mid-stage, but the biotech still eyes a Phase 3 path

An Alzheimer’s disease drug from Athira Pharma has failed a Phase 2 clinical trial and the biotech has a surprising theory why. Athira says standard of care drugs Alzheimer’s patients are already taking may diminish the effect of its small molecule and this finding could inform how the company proceeds with an ongoing Phase 3 …

Athira Alzheimer’s drug fails mid-stage, but the biotech still eyes a Phase 3 path Read More »

Human Longevity strikes a SPAC deal to go public and fuel U.S., global expansion

Human Longevity, Inc., a startup founded by genomics pioneer J. Craig Venter, plans to join the public markets via a SPAC merger. If the business combination closes, HLI would receive about $345 million for continued commercialization of its platform that uses genomics, AI, and other technologies for early disease detection and other strategies intended to …

Human Longevity strikes a SPAC deal to go public and fuel U.S., global expansion Read More »

Aiming to catch Alnylam, AstraZeneca & Ionis plan FDA filing for rare disease drug

The planned FDA submission follows the report from AstraZeneca and Ionis Pharmaceuticals that their partnered drug, eplontersen, met the main goals of a pivotal study in treating nerve pain caused by hereditary transthyretin-mediated amyloidosis. The data come one week after rival Alnylam Pharmaceuticals won FDA approval for its second drug for this rare disease.

AbbVie’s blockbuster drug Skyrizi gets FDA nod for treating Crohn’s disease

AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation. In other drug decision news, the Rhythm Pharmaceuticals product Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication.

Pfizer, Moderna Covid-19 vaccines are now authorized for kids as young as 6 months

Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease Control and Prevention signs off on these shots this weekend, these pediatric vaccines could become available for distribution early next week.

Prepping for FDA approval, Grail is partnering with health systems to validate its pan-cancer test

Grail, a company focused on early cancer detection, introduced its test that screens for more than 50 kinds of cancer last year. At AWS’ Thursday conference for healthcare and life sciences innovation, the company’s chief security officer explained how the company is evaluating the test in clinical trials and preparing to file for its FDA …

Prepping for FDA approval, Grail is partnering with health systems to validate its pan-cancer test Read More »

November will bring political change. Will it also change drug prices and PDUFA?

Drug prices are on the minds of patients and politicians. The November election is expected to tip the balance of power in Congress and a panel held during the Biotechnology Innovation Organization’s annual meeting discussed what that change could mean for drug price legislation.

BIO panel: How Covid-19 is preparing us to better respond to the next pandemic

Biopharmaceutical companies and public health officials have learned a great deal about pandemic response in the last two years. A panel discussion during the annual meeting of the Biotechnology Innovation Organization explored some of the lessons from Covid-19 and how they can prepare us for the next pandemic.

Creating better alignment between digital and pharma sectors

At the MedCity INVEST PharmaTech virtual conference July 26, strategies and alignment between digital and pharma companies will be a major theme of the conference. Register now to join the conversation.

ImCheck fetches €96M for antibodies that activate immune cells against cancer

ImCheck Therapeutics aims to broaden the reach of cancer immunotherapy with antibody drugs that activate a rare but powerful type of immune cell called gamma delta T cells. The biotech has unveiled €96 million to advance its pipeline, including a lead candidate in development for both liquid and solid tumors.

At BIO, French delegation highlights its plans for healthcare and biotech development [Sponsored]

The French delegation at BIO on June 13-16 has a compelling story to tell about biopharma and medtech growth and investment in France and the U.S. Here’s a preview of some of the companies that will be at the convention, events they will host and why you should check them out.

Tessa Therapeutics takes in $126M for cell therapies, and more biotech financings

Ten biotech companies were able to raise more than $500 million in combined financing in the past week. Here’s a recap of the funding activity, which spanned AI-based drug discovery, cell therapy clinical research, cancer drug development, and more.

How digital is transforming the commercial leader’s role in biopharma

Pharma’s evolving role in patient care The digital revolution has already reshaped the commercial engine of biopharma companies. Pharma’s digital initiatives now routinely enable new channels that educate and market to patients, physician engagement that is more efficient and effective, and novel payment mechanisms and distribution models that improve access to therapies. The pandemic accelerated …

How digital is transforming the commercial leader’s role in biopharma Read More »

GSK immunotherapy shows promise as alternative to surgery in certain rectal cancers

A small Memorial Sloan Kettering Cancer Center study found that all rectal cancer patients treated with GSK drug Jemperli showed a complete response at six months—there were no detectable signs of the cancer. These early data presented at ASCO suggest that rectal cancer with a particular genetic signature might be treatable with this immunotherapy in …

GSK immunotherapy shows promise as alternative to surgery in certain rectal cancers Read More »

The state of AI in drug discovery

The MedCity INVEST PhrmaTech virtual conference, scheduled for Tuesday, July 26, offers free registration and a compelling day of conversations exploring the convergence of the health tech and biopharma sectors.

ASCO recap: Breast cancer breakthrough, Mirati’s moves, Arcellx ascends & more

Breast cancer drugs and cell therapies were prominent in this year’s annual meeting of the American Society of Clinical Oncology. Here’s a recap of some of the news highlights from the biggest cancer conference of the year.

Measure your omnichannel maturity with our new tool

Our Omnichannel Maturity tool is designed for biopharmaceutical, healthcare technology, and wellness companies that are driven to develop integrated and customer-centric omnichannel experiences. This simple 8-question quiz is divided into 4 sections to help you understand your organization’s level of omnichannel maturity. Once you have completed the questionnaire, you will receive tangible recommendations and an …

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PMV’s ASCO data show signs of drugging ‘undruggable’ p53 protein across tumor types

PMV Pharmaceuticals has its first clinical data showing that its lead therapeutic candidate can hit p53, a tumor-suppressing protein long thought to be undruggable. After reporting the preliminary data during ASCO, PMV said it plans to continue Phase 1 study with the goal of advancing to Phase 2 early next year.

Code Bio corrals $75M to skip viruses, use synthetic DNA for genetic meds delivery

Code Biotherapeutics uses synthetic DNA as the foundation for its genetic medicines, which the startup claims offer several key advantages compared to genetic medicines delivered via engineered viruses. The startup plans to use its new capital to develop lead programs in Duchenne muscular dystrophy and type 1 diabetes.

AstraZeneca, Daiichi Sankyo have high hopes for drug that goes low in breast cancer

During the annual meeting of the American Society of Clinical Oncology, AstraZeneca and Daiichi Sankyo reported pivotal clinical trial data showing that their partnered cancer drug Enhertu can treat a group of patients previously thought to be out of reach for a targeted therapy. The results suggest use of this FDA-approved drug could significantly expand …

AstraZeneca, Daiichi Sankyo have high hopes for drug that goes low in breast cancer Read More »

Gilead offers more detail on breast cancer drug’s trial results. Is it enough?

Gilead Sciences has more detail about breast cancer drug Trodelvy, a blockbuster hopeful it acquired two years ago. Additional data from a pivotal study were presented during the annual meeting of the American Society of Clinical Oncology and they still leave many questions unanswered.

BMS bets $4.1B on lung cancer drug that could best products from Pfizer, Roche

Bristol Myers Squibb is splashing out $4.1 billion to acquire Turning Point Therapeutics, a clinical-stage biotech whose lead drug is currently in pivotal testing as a treatment for certain lung cancers. Recently reported preliminary data suggest the small molecule could have advantages over currently available drugs in the same class from rivals Pfizer and Roche.

Regeneron is paying $900M for full rights to cancer drug partnered with Sanofi

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.

Repare relinquishes cancer drug to Roche, gets $125M to finance growing pipeline

Roche’s deep oncology pipeline is adding a drug candidate from Repare Therapeutics that works by interfering with a DNA repair mechanism of cancer cells. Repare receives $125 million up front and it retains the right to share in the development and commercialization of the drug, camonsertib.

Report: Omnichannel advice for the life science industry

In the healthcare sector and beyond, the adoption of digital tools and novel analytics has exploded. However, unlike many consumer industries, biopharma, medical technology, and wellness companies have struggled to build meaningful personalized customer experiences. Today, biopharma and med tech executives are faced with numerous channels, novel technologies, and a high volume of data. They struggle …

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After Haleon splits from GSK, Pfizer plans to cash out to the tune of $16B

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.

GSK gets pneumococcal vaccine contender with $2.1B Affinivax acquisition

Pfizer and Merck have each won FDA approvals in the past year for new pneumococcal vaccines, but GSK aims to top both of them with its $2.1 billion acquisition of Affinivax. That biotech’s Phase 3-ready vaccine candidate addresses more bacterial strains than any pneumococcal vaccines currently available.

ASCO 2022 ahead: Clinical trial updates and data readouts to watch for

The American Society of Clinical Oncology’s annual meeting begins this week, including the presentation of more than 2,800 abstracts. Amgen, Roche, and Sierra Oncology are among the companies with key presentations at this year’s gathering.

Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more

Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee meeting scheduled to discuss the use of that vaccine and Moderna’s in kids. In other Covid news this week, the CDC issued a health advisory for Pfizer’s antiviral Paxlovid and …

Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more Read More »

It’s time to integrate liquid biopsy into colorectal cancer treatment decision-making

Since it measures the total amount of circulating DNA (ctDNA) in a patient’s bloodstream using a simple blood draw, ctDNA liquid biopsy tests offers oncologists with an accurate, molecular, real-time cancer detection tool. It also helps to determine cancer staging and can help assess how aggressive the treatment regimen should be.

New Flagship Pioneering startup expands the protein universe to fuel drug discovery

ProFound Therapeutics emerged from stealth with technology that it claims has discovered tens of thousands of previously undiscovered proteins—many of them promising new drug targets. The Flagship Pioneering-founded startup is backed by $75 million to support its drug R&D along with plans to partner with large pharmaceutical companies.

Heart trouble report & clinical hold spell end of Antios, Assembly Bio HBV alliance

A clinical hold on an Antios Therapeutics drug has led to the end of a collaboration with Assembly Biosciences less than a year after their alliance began. The partners had hoped pairing their drugs with an approved Gilead Sciences antiviral would produce a combination hepatitis B treatment with the potential for a cure.

FDA approves Roivant drug, the first novel topical plaque psoriasis med in 25 years

Plaque psoriasis drug Vtama is now approved by the FDA, making it the first novel topical treatment for the chronic autoimmune disorder in a generation. Roivant Sciences subsidiary Dermavant Sciences acquired the drug from GlaxoSmithKline in 2018.

What has Covid-19 taught us about virtual clinical trials?

At the upcoming INVEST PharmaTech virtual conference scheduled for July 26, the conversations will span myriad topics at the intersection of digital health and drug development. Register today.

Biohaven drug fails another clinical test, this time in rare neuromuscular disorder

Biohaven’s migraine drug research led to an FDA-approved product with strong commercial uptake, but its other neuroscience efforts have yet to achieve the same outcomes. Drug candidate troriluzole has failed a Phase 3 test in neuromuscular disorder spinocerebellar ataxia, the molecule’s third failure in a pivotal study in the past two years.

Innoviva’s Entasis acquisition brings a novel antibiotic that’s ready for the FDA

Entasis Therapeutics is being acquired by Innoviva in a deal that brings an FDA-ready antibiotic developed to address drug-resistant strains of a bacterium that infects critically ill, immunocompromised patients. Innoviva has been steadily building up its stake in Entasis, an AstraZeneca spinout, over the past two years.

CAR T without the toxicity: Kelonia gets $50M for a new take on cell therapy

Kelonia Therapeutics is developing cell therapies made by the in vivo engineering of a patient’s cells made possible by the targeted delivery of a genetic payload. The startup, newly out of stealth with $50M in funding, claims its approach would offer manufacturing and safety advantages over other cell therapy technologies.

FDA sounds caution on Foghorn cancer drug with a partial hold after patient death

The lead cancer drug candidate of Foghorn Therapeutics is now under a partial clinical hold following a patient death. According to the biotech, the patient may have experienced a side effect that is a known complication of leukemia drugs.

Enanta RSV drug fails a Phase 2 test, but studies continue in higher-risk patients

An antiviral that Enanta Pharmaceuticals is developing for respiratory syncytial virus infection failed to beat a placebo in its first Phase 2 test. But the biotech notes that these study participants weren’t very sick and may have recovered on their own, so it’s now pinning its hopes on ongoing studies in higher-risk groups, such as …

Enanta RSV drug fails a Phase 2 test, but studies continue in higher-risk patients Read More »

Flagship merges two of its biotechs to form cellular microenvironment-focused Sonata

Sonata Therapeutics is developing drugs that reprogram cellular microenvironments to send signals intended to have curative effects. Cancer is the initial focus of the biotech, which Flagship Pioneering formed by combining two of its preclinical portfolio companies.

INVEST Pitch Perfect winner: makes Tina the Alexa of clinical trials has developed a conversational AI system that replaces in-person interviews that are part of neurological assessments for a range of disorders. The startup was judged co-winner in the pharmatech category during the recent MedCity INVEST conference in Chicago.

Clover Therapeutics turns a new leaf as Character Bio to pursue dry AMD & more

Dry age-related macular degeneration currently has no FDA-approved treatments but the research of Clover Therapeutics has yielded two candidates. The biotech startup has made progress in the past two years under CEO Cheng Zhang and it’s now revealing more details about its approach, a new corporate identity, and a Series A financing that puts it …

Clover Therapeutics turns a new leaf as Character Bio to pursue dry AMD & more Read More »

To focus on cancer, Chimerix sells rights to antiviral drug that defined the biotech

Chimerix is selling global rights to smallpox drug Tembexa, the biotech’s only FDA-approved product, as a way to fund clinical development of a therapy in pivotal testing for a rare type of brain cancer. The deal marks Chimerix’s nearly complete departure from the antiviral work that defined the company for most of its history.

Claiming Akebia agreement breach, Otsuka seeks to end anemia drug pact

Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, vadadustat, and asked for another clinical trial. Otsuka alleges unspecified breaches of the agreement by Akebia, and ending the alliance early could spare it from spending hundreds of millions of …

Claiming Akebia agreement breach, Otsuka seeks to end anemia drug pact Read More »

UCB’s FDA setback delays competition in U.S. with blockbuster J&J psoriasis drug

The FDA cited manufacturing issues in turning down UCB’s application seeking approval for bimekizumab, an antibody drug developed to treat moderate-to-severe plaque psoriasis. Bimekizumab is already approved and available in other markets around world, but the FDA rejection delays UCB’s antibody drug from competing in the U.S. for now.

BMS builds on BridgeBio alliance, inking deal for rights to KRAS cancer drug

Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some needed cash as it restructures in the wake of the Phase 3 failure of its lead program late last year.

Startup Nuvig Therapeutics gets $47M to bring immune system back into balance

Nuvig Therapeutics is developing drugs that tap into one of the body’s natural mechanisms for controlling inflammation. Co-founder and CEO Pamela Conley, a veteran of Portola Pharmaceuticals, says Nuvig’s approach could offer efficacy similar to currently available autoimmune drugs but with a better safety profile.

Closely watched Roche drug fails a second pivotal test in lung cancer

Roche reported that its drug tiragolumab failed to achieve one of two main goals of a Phase 3 study in non-small cell lung cancer. The antibody is designed to block TIGIT, a checkpoint protein that has been a hot target for pharmaceutical companies looking for a way to broaden the reach of cancer immunotherapy.

Pfizer buys its way into migraine with $11.6B Biohaven Pharma acquisition

Pfizer is turning to M&A to get its next blockbuster, buying Biohaven six months after the two companies began a commercialization pact centered on the oral migraine drug Nurtec. The acquisition will lead to the spinout of Biohaven’s other assets into a new, publicly traded company capitalized with $275 million.

Aiming to treat Parkinson’s by replacing neurons, Aspen Neuroscience nabs $147M

Aspen Neurosciences is developing a cell therapy that uses a patient’s own stem cells to develop a personalized treatment for Parkinson’s disease. The approach is slightly different than that of Bayer, whose experimental Parkinson’s cell therapy is made from stem cells sourced from healthy donors.

How cell & gene therapy startups can warm up to investors in this “biotech nuclear winter”

Cell and gene therapy research has been hot the past few years but the overall market has cooled down in recent months. During the World Medical Innovation Forum in Boston, a panel of venture capitalists discussed capital formation and what biotech firms need to do to win over investors and advance their research.

Regulatory recap: J&J vaccine limits, full Enhertu approval, a Vertex hold & more

The FDA amended emergency authorization of Johnson & Johnson’s Covid-19 vaccine. In other regulatory news this past week, drug approvals include a cancer drug that converted its accelerated regulatory approval to a full regulatory nod, while several companies dealt with rejections or clinical trial setbacks.

PepGen IPO nabs $108M for muscular dystrophy drug with potential edge over Sarepta med

PepGen’s technology improves the delivery of a therapy to more tissue types and the clinical-stage biotech plans to use its IPO cash to continue developing its lead program for Duchenne muscular dystrophy. Meanwhile, eye products giant Bausch + Lomb returned to the public markets as a standalone company. Both the PepGen and Bausch + Lomb …

PepGen IPO nabs $108M for muscular dystrophy drug with potential edge over Sarepta med Read More »

Are you a startup seeking to transform clinical trials? Here’s why you should apply to pitch at INVEST PharmaTech.

INVEST PharmaTech Pitch Perfect virtual conference July 26 will give startups the opportunity to present their approaches to clinical trial innovation to a team of investor judges. Apply today!

Biogen gets in tune with MedRhythms to develop new digital therapeutic for MS

Biogen struck a deal that could bring a digital therapeutic to its multiple sclerosis product portfolio. The drugmaker is partnering with startup MedRhythms in the development of a therapy that combines sensors, software, and music to improve walking problems in multiple sclerosis patients.

BMS shows what’s NEX-T for CAR T, plus its strategy for next-gen cancer cell therapy

As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.

WMIF panel: How cell and gene therapy can overcome limitations of CAR T

CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical Innovation Forum discussed efforts to improve CAR T as well as new approaches for the next generation of cell therapies.

California opens Medicaid to older unauthorized immigrants

Unauthorized immigrants over age 49 who fall below certain income thresholds are now eligible for full coverage by Medi-Cal, California’s version of Medicaid. If Gov. Gavin Newsom gets his way, which seems entirely plausible considering the state’s rosy financial outlook, California could allow all remaining low-income unauthorized immigrants — an estimated 700,000 people — to …

California opens Medicaid to older unauthorized immigrants Read More »

Kelonia Therapeutics Emerges with $50M to Deliver Precision Targeted Genetic Medicines

What You Should Know: – Kelonia Therapeutics, a Boston-based biotech company focused on vivo gene delivery, launched with a $50 million in Series A funding to expand the benefit and reach of genetic medicines. – Despite life-changing responses, existing gene therapies are highly complex, costly, and limited by complicated treatment paradigms, tractable therapeutic applications, and …

Kelonia Therapeutics Emerges with $50M to Deliver Precision Targeted Genetic Medicines Read More »

HilleVax’s IPO hauls in $200M for clinical test of VLP norovirus vaccine from Takeda

Takeda Pharmaceutical spinout HilleVax broke the biotech IPO drought with a $200 million stock market debut for clinical development of a norovirus vaccine. Two eye health companies marked the other IPO activity: Belite Bio went public while Bausch + Lomb set financial terms for what could become one of the biggest IPOs of the year.

Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease

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.

INVEST Pitch Perfect winner: Athelo helps patients navigate cancer journey

Athelo Health’s software is a personal coach that supports women with breast and gynecological cancers. The startup was judged co-winner in the pharmatech category during the recent MedCity INVEST conference in Chicago.

Biohaven migraine drug partnered with Pfizer lands twin European approvals

The European Commission approved Biohaven Pharmaceuticals migraine drug rimegepant. While the regulatory decision marks another milestone for Biohaven, it’s also a win for Pfizer, which holds rights to commercialize the drug outside of the U.S.

Cancer biotech Pheast unveils $76M to expand immunotherapy’s menu to new targets

Biotech startup Pheast is out of stealth taking a tack similar to that of cancer immunotherapy company Forty Seven, also a spinout from the Stanford University lab of Irving Weissman. While both companies get immune cells to eat tumors, Pheast’s technology has the potential to take the approach to a broader range of cancer types …

Cancer biotech Pheast unveils $76M to expand immunotherapy’s menu to new targets Read More »

Biofourmis adds $300M to ramp up in virtual care, digital therapy clinical trials

The Series D round of funding makes Biofourmis a unicorn valued at $1.3 billion. CEO and founder Kuldeep Singh Rajput said that the new capital will be used to expand his company’s remote-monitoring technologies and continue development of digital therapeutics, both as companions to traditional drugs and as monotherapies.

Gandeeva CEO shares how integrating AI with cryo-electron microscopy can support drug discovery

Founded in 2021, Gandeeva is developing precision imaging solutions with the integration of cryo-electron microscopy (cryo-EM) and artificial intelligence. Its technology can be applied to advance drug discovery and by lowering risks of late-stage clinical failures.

Nkarta’s natural killers flash potential as next-gen cell therapies for cancer

Two natural killer (NK)cell therapy candidates from Nkarta now have preliminary Phase 1 clinical data suggesting these therapies are helping patients in two types of blood cancers. Nkarta therapies based on engineered NK cells could offer both efficacy and safety advantages over the first generations of cell therapies, which are made from a patient’s own …

Nkarta’s natural killers flash potential as next-gen cell therapies for cancer Read More »

Roche breast cancer drug fails in Phase 2 following similar stumble by rival Sanofi

Experimental Roche drug giredestrant failed to meet the main goal of a Phase 2 study in advanced breast cancer. The disappointing results allow competitors to gain ground in the field of companies developing oral selective estrogen receptor degraders (SERDs), drugs that block a receptor key to driving breast cancer growth.

Covid-19 vaccines & therapies helped push medicines spending to $407B in 2021

While Covid-19 has had a significant impact on drug spending, IQVIA projects that its effect will moderate in coming years. IQVIA’s new report on U.S. medicines spending projects that immunology, oncology, and neurology will continue to drive the growth in drug spending.

Biogen pulls Alzheimer’s drug application in Europe as EMA calls data insufficient

Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.

AstraZeneca’s long-acting Covid-19 drug keeps protecting high-risk patients at 6 months

AstraZeneca’s Covid-19 antibody drug Evusheld reduced the risk of infection by 83% after six months. These results published in the New England Journal of Medicine are the latest clinical data supporting the durability of Evusheld, which was designed to offer longer-lasting protection.

BMS joins Octant’s $80M financing and signs on as a drug discovery partner

Octant Bio’s synthetic biology approach to drug discovery is making progress, and the preclinical biotech has raised $80 million in Series B financing to continue the journey. The company added Bristol Myers Squibb as an investor and collaborator in the search for new immunology drugs.

Regenerative med biotech Satellite unveils tissue-based tech to restore organ function

Satellite Bio has emerged from stealth with technology for bioengineering tissue to restore organ function. The regenerative medicine startup, based on research from MIT and Boston University, is backed by $110 million in financing.

AI startup Unlearn adds $50M for better, faster, smaller & cheaper clinical trials

Unlearn.AI’s Series B round follows a positive European Medicines Agency draft opinion finding that the company’s artificial intelligence technology can be used in Phase 2 and Phase 3 clinical trials. The startup is now on the hunt for pharmaceutical partners that want to use the technology to speed up their clinical research.

Regeneron captures new piece for cancer with $250M Checkmate Pharma buyout

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.

FDA’s tighter scrutiny on drug class leads TG Therapeutics to pull out of cancer

TG Therapeutics is pausing its cancer drug research and withdrawing the approved cancer drug Ukoniq from the market. The move comes as the FDA places greater scrutiny on Ukoniq’s drug class—concerns that will be discussed during an FDA advisory committee meeting scheduled for April 21.

Covid news roundup: Boosters for kids, breath diagnostic, a vax approval & more

Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid news, a vaccine developer won marketing authorization in Europe while another one faces a regulatory setback.

A biotech’s bold vision to turn stem cell transplants into outpatient procedures

Versant Ventures has launched Cimeio Therapeutics, a biotech startup with technology that can shield transplanted stem cells or cell therapies. Shielding these cells enables them to be dosed alongside an immunotherapy—an approach that is not currently done because the therapies don’t discriminate between diseased cells and transplanted ones.

BMS and Nektar end cancer drug alliance after two more clinical trial failures

Bristol Myers Squibb and Nektar Therapeutics are ending a cancer drug research alliance after data showed the combination of their respective drugs failed clinical trials in kidney and bladder cancers. The disappointing results come one month after the drug combo failed a pivotal melanoma clinical trial.

Cell therapy developer Be Bio hauls in $130M for pipeline in rare disease, cancer

Be Biopharma is developing cell therapies by engineering B cells to churn out therapeutic proteins with an initial focus on cancer and rare disease. The company’s Series B financing comes as competitors in the space also make progress with their engineered B cell therapies.

GlaxoSmithKline expands its cancer scope with $1.9B Sierra Oncology acquisition

GlaxoSmithKline is further building out its cancer drug portfolio by acquiring Sierra Oncology, a biotech whose FDA-ready myelofibrosis drug has clinical data showing advantages over a blockbuster product marketed by Incyte. The deal comes as GSK prepares a spinoff of its consumer products as part of a broader strategy to hone its focus on specialty …

GlaxoSmithKline expands its cancer scope with $1.9B Sierra Oncology acquisition Read More »

Planning ahead while looking back: What the pandemic collectively taught us

As artificial intelligence becomes more focused and efficient, and the pharmaceutical and biotech industries consolidate to survive, it’s important to also reflect on what is working in the fight against Covid-19. This will help us to be more prepared for the next global health crisis.

Cell therapy biotech Aurion gets $120M to restore vision and revamp organ donor economics

Organ donation has long been a matter of demand outstripping supply, but Aurion Biotech aims to improve the supply part of the equation with a cell therapy. Aurion’s technology turns a single donated cornea into treatments for up to 100 patients and the startup now has $120 million for clinical trials.

CEO of upstart PBM: What CVS, Cigna and other PBMs are doing in drug pricing is neither sustainable nor ethical

A.J. Loiacono was speaking at MedCity INVEST in late March in Chicago when an audience member requested him to address whether it is sustainable to have a system where after insurance a drug costs $150 for consumers whereas with GoodRx the same drug is $6. Loiacono took aim at PBMS but also didn’t spare the …

CEO of upstart PBM: What CVS, Cigna and other PBMs are doing in drug pricing is neither sustainable nor ethical Read More »

FDA gives Gilead reprieve on partial hold for cancer drug studies

An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead drug, magrolimab, is part of a class of cancer immunotherapies that address a hot target for the field.

Startup Ansa Bio lands $68M to go long with enzymes approach to DNA synthesis

The DNA currently used in genetic medicines research is synthesized by chemical methods. Ansa Biotechnologies employs faster and less expensive enzymes-based technology, and the startup has raised capital to scale up operations as it prepares to launch its service.

Aiming to make better mRNA vaccines, BioNTech strikes up alliance with Matinas

Oral delivery of messenger RNA is one of the capabilities of Matinas BioPharma’s technology. BioNTech will explore that feature among others under a new research alliance with Matinas, a clinical-stage biotech that also has an ongoing collaboration with Genentech.

Microbiome biotech Kaleido Biosciences shutters amid cash crunch, drug setbacks

Kaleido Biosciences, formed by Flagship Pioneering as part of a wave of biotech companies developing microbiome therapies, has laid off its entire workforce and is winding down operations. The shutdown follows a strategic review that failed to turn up any deals to support its clinical-stage pipeline.

Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical trials

Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.

Werewolf cancer drug strikes right note with Jazz Pharma, sparking licensing deal

Jazz Pharmaceuticals is licensing rights to a Werewolf Therapeutics cytokine therapy that’s on track to reach clinical testing next year. The deal gives Jazz a drug candidate that expands the company’s scope to immuno-oncology.

Pfizer broadens its RSV reach with deal for ReViral and its clinical-stage antivirals

Pfizer is already in the mix of companies pursuing vaccines for respiratory syncytial virus. The pharma giant is now broadening its scope with a deal to acquire ReViral Therapeutics, a biotech with two clinical-stage antivirals, each taking a different approach to stopping the potentially deadly pathogen.

INVEST PharmaTech: The convergence of digital health and biopharma

MedCity INVEST PharmaTech, a virtual conference scheduled for July 26, will bring together technology disruptors, Big Pharma and biotech leaders, investors and entrepreneurs to discuss how to adopt digital strategies to transform every aspect of the pharma industry.

Novartis cancer drug is now first approved therapy for group of rare, genetic diseases

A Novartis drug that stops abnormal cell growth in breast cancer now has an additional FDA approval treating a group of rare disorders characterized by overgrowth in various types of tissue. The regulatory decision makes the drug, Vijoice, the first approved therapy for these disorders termed “PROS.”

Imara’s two trial flops in blood disorders dim drug’s prospects in heart failure

The lead drug candidate of Imara failed two separate mid-stage clinical trials evaluating it in rare, inherited hemoglobin disorders. Imara had been planning to advance the small molecule to yet another Phase 2 study in heart failure, but in light of the twin trial failures, the biotech is now weighing “strategic options.”

Takeda returns to Evozyne’s AI tech, seeking novel proteins for next-gen gene therapies

Evozyne uses artificial intelligence and machine learning to design novel proteins that can be used in gene therapies. The new agreement with Takeda Pharmaceutical covers the development of proteins that can be used in gene therapies for rare diseases.

FDA places partial hold on Curis cancer drug after patient death in clinical trial

The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The biotech company said the patient experienced a complication that is a known risk of the small molecule drug.

AXA beefs up life sciences investments with $500m push

Multinational insurance company AXA has launched a new €440 million ($500 million) drive to provide private equity investments in healthcare companies that deepens its interest in the life sciences sector. Until now, AXA Investment Managers has been focused more on the delivery end of health care – health centres and private hospitals, for example – …

AXA beefs up life sciences investments with $500m push Read More »

Bayer reloads Leaps with €1.3 billion to step up investments in biotech innovation

Bayer is committing another €1.3 billion to Leaps by Bayer, the company’s investment arm, to support additional investments in companies developing innovative technologies in healthcare and agriculture. In addition to backing companies developing cell and gene therapies, Leaps has also deployed its cash to startups developing artificial intelligence technologies for a range of applications.

Becton Dickinson spins off diabetes biz, enabling Embecta to embark on its own

The second quarter of 2022 kicked off with a new life sciences company joining the public markets, but not via an IPO or merger. Becton Dickinson on Friday completed the spinoff of its diabetes care business, Embecta, which now trades on the Nasdaq.

Safety concerns sink Akebia drug for anemia from chronic kidney disease

The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety concerns and asked for another clinical trial to show that the pill’s benefits outweigh its risks.

Vying to best bigger rivals in Parkinson’s, Neuron23 nabs $100M to reach clinic

Neuron23 is developing drugs that treat neurological conditions by penetrating the blood-brain barrier to reach disease targets in the central nervous system. The biotech’s lead program is a Parkinson’s disease drug candidate with features that could distinguish it from rival compounds that are aiming for the same target.

As cash keeps pouring into health startups, VC firms work to stay disciplined

Venture capital investment in healthcare startups is continuing at a steady pace. Is it too much? Is a correction coming? Three investors offered their perspectives during a panel discussion at MedCity News’s INVEST conference in Chicago.

Data and regulatory roundup: Pfizer’s feat, an ADHD miss, Eli Lilly’s CRL & more

A pharmaceutical giant reported a Phase 3 success for a potential blockbuster drug, while four other companies reported disappointing data from their respective clinical trials. Our recap of data readouts and regulatory news also includes one FDA rejection.

AN2 Therapeutics’ IPO raises $69M to take antibiotic from Pfizer into pivotal test

AN2 is developing an antibiotic based on boron chemistry that could offer advantages over carbon-based molecules. The biotech plans to advance its drug candidate, licensed from Pfizer, to a pivotal test in a rare and potentially fatal lung infection caused by mycobacteria.

Ligand Pharma turns to a SPAC to take antibody biz public, raise up to $266M

OmniAb, the antibody division of Ligand Pharmaceuticals, is set to go public through a SPAC merger that will infuse the business with up to $266 million. The deal comes as traditional IPOs have mostly ground to a halt due to uncertain market conditions, but Ligand is making a longer-term bet on growing demand for antibody …

Ligand Pharma turns to a SPAC to take antibody biz public, raise up to $266M Read More »

Celsius Therapeutics heats up with $83M and an IBD drug on path to the clinic

Single-cell analysis biotech Celsius Therapeutics has raised $83 million to advance its pipeline of drugs for autoimmune disorders and cancer. The startup’s lead autoimmune program, a TREM1-blocking antibody for inflammatory bowel disease, is expected to begin human testing in early 2023.

GSK joins LifeMine’s $175M funding as partners revive fungi as a drug discovery frontier

LifeMine Therapeutics, a company that analyzes fungal genomes to find molecules that have potential as new medicines, has raised $175 million in financing. Among the investors is GlaxoSmithKline, which is teaming up with the biotech startup in a multi-target drug discovery alliance.

Cell therapy biotech Affini-T gets $175M; KRAS is lead genomic cancer target

Affini-T Therapeutics is developing new cell therapies for cancer that could overcome limitations of the first generation of cell therapies. The initial genomic cancer targets of the startup are mutations of KRAS and p53, both of which have proven difficult to drug.

Study: Machine learning successfully tracks drugs stolen from hospitals faster and with minimal error

A retrospective study published in American Journal of Health-System Pharmacy found that machine learning and advanced analytics technology not only identifies drug diversion – when drugs are stolen from hospitals – but also that the tech can do so 160 days faster than standard methods, and with a 96.3% accuracy rate.

FDA approves Marinus Pharma drug for rare, genetic form of epilepsy

Marinus Pharmaceuticals drug Ztalmy is now FDA approved for treating the seizures in patients who have CDKL5 deficiency, an inherited form of epilepsy. The drug is the first approved treatment for the rare disorder and it’s also Marinus’s first approved product.

BMS nabs FDA nod for first drug in new class of cancer immunotherapies

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.

Apellis Pharma eyes a shot at getting first FDA approval in rare vision disorder

Apellis Pharmaceuticals has additional clinical data that show its drug having an effect on geographic atrophy, a rare vision-loss disorder with no FDA-approved treatment. The biotech plans to include the latest results in a new drug application being readied for submission in coming months.

Diabetes data put Better Therapeutics’ digital offering on track for FDA filing

Better Therapeutics reported that its digital therapeutic for type 2 diabetes met the main goal of a pivotal study. An FDA submission is expected in the middle of this year, followed by additional clinical trials testing digital therapeutics developed for other cardiometabolic disorders.

RNA biotech Nutcracker Therapeutics unshells $167M for drugs built on biochips

ARCH Venture Partners led the Series C round of financing for Nutcracker Therapeutics, a company developing new RNA drugs. The company’s process for developing and manufacturing RNA therapies borrows from techniques used in the technology sector.

Nektar drug key to muti-billion dollar BMS deal fails pivotal test in melanoma

Bristol Myers Squibb bet more than $1.8 billion that Nektar Therapeutics’ drug could be combined with the pharma giant’s Opdivo to expand the reach of that drug to more patients. The drug combination has failed its first Phase 3 in advanced melanoma; separate studies in kidney and bladder cancers are ongoing.

Creyon Bio gets some green for a new take on AI and genetic meds R&D

Creyon Bio is the latest company to launch with artificial intelligence technology for drug R&D. The startup claims it’s technology can provide sufficient safety and toxicity to enable a therapy to bypass the animal research currently needed before clinical trials.

Modest activity, tolerability issues sink lead Harpoon cancer drug prospect

Harpoon Therapeutics is discontinuing work on its lead drug in prostate cancer following disappointing data in an early-stage clinical trial. Though Harpoon has other drugs in its pipeline, the decision is a setback to the company’s efforts to develop a new type of cancer immunotherapy.

MorphoSys cuts R&D from Constellation deal to focus on clinical-stage cancer drugs

MorphoSys is cutting the drug discovery and R&D work of Constellation Pharmaceuticals, a company it acquired lats year in a $1.7 billion deal. This consolidation of research operations will result in non-cash impairment charge on Constellation’s goodwill.

Scenic Biotech scores $31M to take aim at genetic modifiers for cancer & rare disease

Targeting mutations isn’t the only way to treat genetically driven diseases. Scenic Biotech is developing molecules to target genes that suppress disease, and it has raised $31 million to advance its pipeline of potential therapies for cancer and rare diseases.

Sanofi’s hemophilia A data set stage for regulatory filings, matchup with Roche

An experimental hemophilia A therapy from Sanofi and partner Sobi has met the goals of a pivotal study, and the pharmaceutical giant is now planning global regulatory submissions for later this year. The drug could compete against a blockbuster hemophilia A treatment marketed by Roche.

Novartis turns to Voyager Therapeutics to get gene therapies into the brain

Novartis is paying Voyager Therapeutics $53 million up front to begin a partnership focused on the discovery of capsids for central nervous system disorder gene therapies. Depending on the progress of the research, Voyager could earn up to $1.5 billion in milestone payments.

Sherlock Biosciences secures $80M to bring molecular diagnostics to the home

Diagnostics developer Sherlock Biosciences has advanced its molecular diagnostic capabilities, which can now produce faster results on low-cost devices. The startup will use its Series B round of funding to expand the reach of its technology, potentially placing it directly in the hands of consumers around the world.

With lung drug from Pfizer in hand, AN2 tests IPO waters in turbulent market

Two biotechs are braving the roiling financial markets to raise money for clinical trials. AN2 Therapeutics is preparing for a pivotal test of its boron-based drug candidate for a rare, chronic lung disease. Okyo Pharma also filed IPO paperwork as it looks to advance to the clinic with its dry eye disease drug.

Alpine Immune Sciences cancer drug trial placed on partial hold after patient death

The FDA placed a partial clinical hold on a Phase 1 study testing experimental Alpine Immune Sciences cancer drug davoceticept in combination with Merck cancer immunotherapy Keytruda. The partial hold does not affect a separate study testing the Alpine drug as a monotherapy.

Princeton spinout ArrePath gets $20M to combine AI, imaging in antibiotics R&D

Anti-infective drug discovery startup ArrePath has launched with $20 million in seed funding to advance the development of molecules that use a dual mechanism to kill bacteria. The Princeton University spinout says its approach could overcome the drug resistance bacteria are developing to currently available products.

Cancer biotech Rondo gets $67M to step on the gas with next-gen bispecific drugs

Rondo Therapeutics is developing bispecific antibody drugs capable of treating solid tumors, which have eluded this type of cancer therapy. Led by co-founders and Teneobio veterans Shelley Force Aldred and Nathan Trinklein, the biotech startup has emerged from stealth backed by a $67 million Series A round of funding.

Flagship’s Vesalius launches with $75M to take AI into realm of common diseases

Artificial intelligence is a powerful tool for rare disease drug discovery. The founders of Vesalius Therapeutics say AI and machine learning can also be applied to common diseases, and the startup has launched with $75 million in committed financing.

AbbVie makes neuro drug connection with $130M Syndesi Therapeutics acquisition

AbbVie has acquired Syndesi Therapeutics, an early clinical neuroscience startup developing drugs that have potential applications in a range of cognitive disorders. Syndesi is based on research from Belgian pharmaceutical company UCB.

Sanofi and DarioHealth team up on digital health tools for chronic conditions

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.

Biocon expands portfolio & market reach with $3.3B buyout of Viatris biosimilars

Biocon Biologics is acquiring the biosimilars business of its longtime partner, Viatris. The deal gives Biocon a biosimilars presence in both emerging and developed markets, while Viatris sheds non-core assets as part of a broader strategic review.

FDA rejects Reata Pharma chronic kidney disease drug; new trial needed

The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in patients who have the rare disease Alport syndrome. The regulatory decision follows an FDA advisory committee vote recommending against approval of the small molecule drug.

Biohaven pays $100M for epilepsy drug prospect; strikes deal for BMS muscle med

Neuroscience drug developer Biohaven Pharmaceuticals is expanding its pipeline to include epilepsy and spinal muscular atrophy. The drug developer is acquiring Channel Bioscience and licensing global rights to a Phase 3-ready drug from Bristol Myers Squibb.

Startup hC Bioscience emerges with $24M to join pursuit of transfer RNA therapies

New startup hC Bioscience is developing therapies based on transfer RNA, molecules that can be leveraged to address disease-causing proteins. The biotech joins several companies that are developing tRNA therapies in this emerging class of genetic medicines.

Amicus rejiggers gene therapy plans as SPAC merger folds in unfriendly market

The SPAC merger that Amicus Therapeutics planned for its gene therapy assets has been called off due to market conditions. The rare disease company is instead keeping those assets but streamlining its portfolio in order to save $400 million—the amount that the gene therapy spinout was in line to receive from the merger deal.

Kodiak Sciences’ trial failure clouds eye drug’s prospects for challenging Eylea

A Kodiak Sciences drug failed to beat a Regeneron Pharmaceuticals product in a key test in the wet form of age-related macular degeneration. The biotech says the failure is due to a subset of undertreated patients, but the results raise the stakes for the drug, its lead product candidate, in other eye diseases.

Sanofi, GSK Covid-19 vax is now ready for regulators; its future may be as a booster

Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster.

Agios strategy shift pays off with FDA approval of first drug for rare anemia

Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment for pyruvate kinase deficiency, a rare disease that leads to chronic anemia.

Cash woes at neuro biotech Yumanity lead to 60% staff cut and search for a buyer

Yumanity’s corporate restructuring means the biotech is now exploring “strategic alternatives” that could include a sale of the company or its assets. The biotech’s lead drug candidate is an experimental Parkinson’s disease drug currently in Phase 1 testing.

J&J partners with startup Remix, aiming to treat disease by “tuning” RNA

Several biotech companies are rising to the challenge of developing small molecules to drug RNA. Remix Therapeutics is joining the chase, but its different approach has drawn the interest of Johnson & Johnson, which has inked an R&D alliance spanning cancer and immunology.