biopharma nl

Seagen, Genmab antibody drug conjugate gets FDA approval in cervical cancer

The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment with chemotherapy. Tivdak is Seagen’s third ADC; for Genmab, the drug will become its first commercialized product.

Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug

The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.

Pfizer reports positive Covid-19 vaccine data in kids; FDA is filing coming

A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.

Repligen sees $150M Avitide acquisition as key to reaching gene therapy goals

Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help it meet growing demand for gene therapy solutions.

FDA panel backs booster shots in high-risk groups after rejecting broader proposal

An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the …

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Brain data startup Rune Labs reveals $23M, plans to rev up neuro drug R&D

Rune Labs developed software that aggregates brain data, providing insights for clinical care and clinical research. Health systems are starting to adopt the technology, and the startup has now raised $22.8 million to grow that part of the business while also expanding use of the technology in drug development.

Takeda therapy gets speedy FDA nod for lung cancers with rare genetic signature

Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.

Dice’s IPO roll comes up with $204M for R&D of oral drugs to rival biologics

Dice Therapeutics raised $204 million from its IPO to support development of oral drugs that could compete against biologic drugs that are injected or infused. Also debuting on the public markets were Tyra Biosciences and Procept BioRobotics.

Neuro startup Vanqua Bio emerges with $85M and a first focus on Parkinson’s

Vanqua Bio aims to treat rare form of Parkinson’s disease by boosting activity of an enzyme that is deficient in patients who have a particular genetic mutation. With $85 million in Series B financing, the biotech startup, which is based on Northwestern University research, aims to reach human testing within two years.

Startup Walking Fish nabs $50M to run with B cell therapies for cancer & more

Walking Fish Therapeutics is developing cell therapies from B cells, a type of immune cell that produces prodigious amounts of proteins. Cancer, autoimmune disease, and regenerative medicine are among the targets of the preclinical-stage biotech, which unveiled $50 million in funding.

AbbVie makes another gene therapy move, paying $370M to partner with Regenxbio

AbbVie will take the lead on commercializing Regenxbio’s gene therapy in wet AMD and diabetic retinopathy. It’s AbbVie’s second major gene therapy deal this year, coming months after it committed $90 million to preclinical-stage Capsida Biotherapeutics.

FDA sets expectations for pediatric Covid-19 vaccines; decision could come mid-fall

Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing of a submission from vaccine developers. U.S. health officials told Reuters they expect the Pfizer/BioNTech vaccine will be the first one ready for an FDA submission.

FDA warns Kaleido Bio to test its Covid-19 candidate as a drug, not a medical food

The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical trial application. Kaleido claims the filing was not required because the product is a medical food, but the regulator doesn’t buy that argument.

Genetic meds pioneer James Wilson has a new startup, this time in gene editing

Biotech startup iECURE is based on work from the University of Pennsylvania scientist, who has been researching ways to use in vivo gene editing as a way to “knock in” healthy versions of a gene to treat rare liver diseases. The company, which will develop therapeutic candidates from Penn, has raised $50 million in Series …

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Startup A-Alpha Bio sets out to solve a major protein problem facing big pharma

A-Alpha Bio’s technology analyzes millions of protein-protein interactions simultaneously, a capability that speeds up drug discovery research. Biotech industry partners are already using the technology and now with $20 million in Series A funding, the startup plans to build machine-learning capabilities to crunch the data produced by all of those protein interactions.

Roche bets $300M on Adaptimmune tech for off-the-shelf cell therapies for cancer

Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also develop a personalized allogeneic cell therapy designed specifically for a patient’s cancer.

Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy

A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study showed that some mice developed liver tumors. Patients did not receive the same high dose that was given to the mice, and no one in the clinical trial has developed …

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The Post-pandemic future of clinical trials: How recruiting, participating and monitoring are changing

Unleashed from restrictive norms for recruiting and interacting with patients, researchers are finding ways to bring more people into trials by simply making enrollment and participation accessible beyond restraints like geography and availability during “business hours.”

Startup Modulus embraces AI to design better NK cell therapies for cancer

Modulus Therapeutics recently emerged from stealth with technology from various disciplines and seed funding that the startup is using to develop better cell therapies. Natural killer cells directed against breast cancer is Modulus’s initial focus, but the startup says its approach can apply to multiple types of immune cells and multiple types of cancer.

Impel NeuroPharma’s drug-device combo product nabs FDA nod for migraine

The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It marks the first approval for the Seattle company, which has developed a proprietary nasal delivery technology.

Novartis “one transplant for life” drug flunks test in kidney transplant patients

A Novartis drug intended to prevent organ rejection has failed to beat out the standard of care therapy in a Phase 2 study in kidney transplant patients. Other clinical trial failures announced ahead of the Labor Day weekend include a Forte Biosciences atopic dermatitis drug, as well a cancer therapy from Takeda Pharmaceutical.

Blood disorder biotech Disc Medicine gets $90M to bring two drugs into Phase 2

A Roche drug that failed as a treatment for neurological disorders is now the lead program for Disc Medicines. CEO John Quisel said Roche’s clinical data showed the small molecule’s promise addressing a rare blood disorder and now the biotech startup has $90 million to advance that drug and another one into Phase 2 testing.

Assembly Bio drops hepatitis B drug after liver problems surface in clinical trial

Four patients dosed with an experimental Assembly Biosciences hepatitis B treatment developed high levels of liver enzymes, a sign of drug-induced liver toxicity. The biotech has decided to stop further work on that drug and focus instead on developing its other clinical-stage hepatitis B drugs.

FDA cracks down on JAK drug class, calls for new warnings of heart, cancer risks

The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency is requiring additional warnings flagging those risks. The updated warnings extend to AbbVie and Eli Lilly medicines in the same drug class.

Asher Bio’s encouraging early data against rival cancer drug sparks $108M financing

Five months after raising $55 million to back a new technology and a promising lead cancer immunotherapy, Asher Biotherapeutics has reeled in $108 million more. CEO Craig Gibbs said investors were enticed by encouraging new data suggesting Asher Bio’s lead program is superior to a competitor’s.

Versanis Bio unveils $70M and a Novartis drug ready for Phase 2 test in obesity

Novartis was unsuccessful developing bimagrumab as a treatment for a rare muscle disorder, but additional tests showed encouraging results in fat reduction. Startup Versanis Bio licensed rights to the antibody and plans to use its Series A financing for clinical trials testing the drug in obese patients.

DeepMind has unlocked protein-based medicine – what does that mean for drug patents?

One of science’s great puzzles is being solved by artificial intelligence and the answers shared freely on the internet. How can life sciences companies make the most of DeepMind’s discoveries while protecting their own?

Pfizer eczema contender beats Dupixent in study, but JAK drug class is still in limbo

Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.

BioMarin stands tall with first approved drug for rare disease that causes dwarfism

The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.

A biotech startup’s hunt for elusive disease targets scores $60M for drug R&D

Atavistik Bio is one of several companies discovering and developing drugs that work by allostery, binding to less obvious sites of a target protein. Acting CEO John Josey said the startup aims to stand apart with its focus on understanding metabolic interactions, a path less trodden by others in allosteric drug discovery.

ADC Therapeutics strikes a $325M royalty deal to fuel its cancer drug strategy

The royalty agreement with HealthCare Royalty Partners will support ADC Therapeutics’ plans to commercialize its newly approved cancer drug and develop the next one in its pipeline. The biotech’s drug Zynlonta is the first of its type approved by the FDA as a treatment for diffuse large cell B-cell lymphoma

Eli Lilly aims for the next-generation of protein degraders via Lycia R&D alliance

Eli Lilly is entering the field of protein-degrading drugs through a partnership with Lycia Therapeutics, a startup whose technology goes further than the first wave of such drugs. Lilly paid $35 million to begin the alliance, which spans up to five drugs.

Emulate CEO shares the organ-chip maker’s vision to understand and predict drug response

Each Organ-Chip is a transparent, flexible microenvironment that contains two parallel chambers that can be configured to grow human cells from an organ of interest, such as the liver, kidney proximal tubule, intestine, lung and brain

FDA approves first drug for severe itching in chronic kidney disease patients

Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the FDA’s nod green light for its injectable drug, Korsuva.

Theravance’s Janssen Biotech-partnered ulcerative colitis drug flops in Phase 2

The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.

Pfizer makes big move in blood cancers with $2.3B Trillium acquisition

Though Gilead Sciences leads the group of companies developing immunotherapies that target the cancer protein CD47, Pfizer contends that molecules it is getting through the Trillium Therapeutics acquisition have safety and efficacy advantages that could make them the best in this emerging drug class.

Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval

Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.

Four biotech startup reel in $238M in financing to ramp up for clinical trials

Vigil Neuroscience led the way with a $90 million round of funding, one of four biotech companies to close Series B financing rounds in the past week. The fresh capital comes as each of the companies looks ahead to bringing their respective drugs into the clinic.

AstraZeneca drug succeeds in Covid-19 prevention; regulatory filings on the way

An AstraZeneca antibody drug for Covid-19 has clinical data showing the drug reduced the risk of infection by 77%. With the results, the pharmaceutical giant pulls ahead of other companies developing injectable versions of antibody drugs for Covid-19 prevention.

AstraZeneca drug acquired in Alexion acquisition falls short in pivotal ALS trial

Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic lateral sclerosis. Despite failing in ALS, Alexion, recently acquired by AstraZeneca, brings additional clinical-stage programs for rare diseases.

Illumina’s Grail buyout beats deadline, but legal and regulatory hurdles remain

In closing its Grail acquisition before U.S. and European regulators sign off, Illumina is taking a chance the deal will pass regulatory muster. It’s a potentially pricey gambit, as Illumina could face fines for its early action and there are no assurances that regulators will agree that the deal is not anticompetitive.

HHS cites real-world data for Covid-19 boosters; WHO says the science is still out

In announcing plans to offer Covid-19 booster shots, federal health officials cited declining vaccine efficacy shown by real-world studies. But the World Health Organization said the science is less than clear about booster shots, adding that it’s ethically wrong to give third shots when so many around the world are waiting for their first one.

Verily adds to its clinical trials toolbox with acquisition of startup SignalPath

Verily’s recent moves have signaled the company’s interest in supporting decentralized clinical trials and real-world studies. Now the life sciences subsidiary of Alphabet is bolstering its capabilities in this these areas with the acquisition of startup SignalPath.

Gritstone secures CEPI funding to test Covid vaccine; first focus is South Africa

Gritstone bio is developing Covid-19 vaccines that use self-amplifying messenger RNA, which is intended to further boost the immune response compared to mRNA alone. The company also says its vaccine candidates may be able to protect against variants of the novel coronavirus.

HiberCell’s Genuity buyout brings $100M, plus alliances with Ionis and AbbVie

Startup HiberCell has acquired Genuity Science, a marriage that brings together two companies that apply AI and machine learning to drug research. HiberCell says Genuity will help the company identify and validate new pathways in how cancer starts and progresses.

Sesen Bio says rejected bladder cancer drug may need new clinical trial

For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.

Merck drug acquired in $1B deal approved to treat tumors sparked by rare disease

FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. Merck added the small molecule to its pipeline two years ago as part of a $1.2 billion acquisition.

HIMSS Digital: Future is bright for payer-provider-pharma collaboration

The pandemic made collaboration necessary between stakeholders that otherwise tend to be at odds with each other. But as partnerships grow, providers, payers and pharma companies must ensure they are working toward a clear-cut common goal, according to panelists at HIMSS 21 Digital.

Eli Lilly joins $30M Series A financing for startup bringing AI analysis to endoscopy

The artificial intelligence-based technology of Iterative Scopes brings computer vision analysis to endoscopic images. The startup’s technology was initially developed to assist gastroenterologists in finding pre-cancerous polyps but CEO and founder Jonathan Ng said it’s also finding additional use helping pharmaceutical companies identify patients for clinical trials.

Ipsen bets on Exicure’s tech as better way to deliver neuro drugs deep into the brain

Ipsen is shoring up its neuroscience pipeline via a deal that gives it the option to license drugs that Exicure is developing for Huntington’s disease and Angelman syndrome. The programs are based on Exicure’s proprietary technology that produces nucleic acid therapies capable of delivery deep into the brain.

Icosavax’s $182M IPO haul is key for RSV, but eyes are on its Covid vaccine too

Icosavax’s research developing a vaccine for a virus that can lead to deadly respiratory infections in the very young and the very old has found an additional application in the pursuit of a vaccine for the novel coronavirus. The biotech’s $182 million IPO gives it the capital to move forward with clinical research on multiple …

Icosavax’s $182M IPO haul is key for RSV, but eyes are on its Covid vaccine too Read More »

Biogen and Eisai unveil details for five-year, real-world Aduhelm clinical trial

Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational study, which is one of three post-marketing clinical programs planned to generate more data about the drug

Ring Therapeutics rounds up $117M to find better viral vectors for gene therapy

The engineered viruses used to deliver gene therapies can spark complications and they can’t be re-dosed. Ring Therapeutics says viruses that evolved with humans can be better viral vectors and the startup has raised $117 million in new financing to continue its research.

Amgen adds antibody assets and R&D tech with $900M Teneobio acquisition

Amgen is paying $900 million up front to acquire Teneobio, a biotech with technology for discovering and developing antibody drugs. Though Amgen already has its own antibody platform, the company says Teneobio’s technology and drug assets will complement its own.

AC Immune picks up Phase 2-ready drug for Parkinson’s in $58M deal with Affiris

AC Immune is bolstering the Parkinson’s disease portion of its drug pipeline with a deal to acquire a therapeutic vaccine that Affiris is developing for the disorder. Switzerland-based AC Immune plans to advance its new asset to Phase 2 testing.

Bristol Myers pulls Opdivo for use in liver cancer amid broader FDA scrutiny of speedy approvals

Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.

Eye problems in more patients spells end of Adverum’s DME gene therapy program

Adverum Biotechnologies still doesn’t know if its experimental gene therapy caused eye problems reported in April in one patient in its diabetic macular edema study. But four others have since developed similar problems, and the company will no longer continue to develop the therapy for that indication.

CRISPR biotech Caribou Biosciences’ IPO reels in $304M for next-gen cell therapy

Caribou Biosciences’ CRISPR approach to cell therapy sparked strong investor interest, enabling the clinical-stage biotech to upsize its IPO and raise $304 million in the biggest life sciences IPO this week. Absci, Sophia Genetics, and Cytek Biosciences also priced IPOs.

Pfizer commits $1B to Arvinas for share of protein degrading breast cancer drug

Arvinas’ early clinical data for its targeted protein degradation drug for breast cancer drew partnering interest from several companies. Pfizer beat them all with a deal that pays the biotech $1 billion to share in the development and commercialization of this therapy.

Seres Therapeutics microbiome drug flunks Phase 2 test in ulcerative colitis

Seres Therapeutics’ ambitions to treat ulcerative colitis with a microbiome drug were dealt a setback as its experimental therapy failed in Phase 2 testing. The company plans a “rigorous scientific analysis” to assess what happened and to determine the next steps for the program.

PacBio’s $600M Omniome buyout brings together long & short of DNA sequencing

DNA sequencing company Pacific Biosciences has reached a $600 million agreement to acquire Omniome, a startup with complementary sequencing technology. The cash and stock deal comes about 18 months after antitrust concerns led PacBio and sequencing giant Illumina to terminate their tie-up.

Amylyx Pharmaceuticals raises $135M as ALS drug heads to pivotal clinical trial

An amyotrophic lateral sclerosis drug from Amylyx Pharmaceuticals is being prepared for Phase 3 clinical testing on track to begin later this quarter. To support that research, the biotech has raised $135 million in financing.

Frontier Medicines raises $88M for R&D, including potential rival to Amgen cancer drug

Cancer drug developer Frontier Medicines already has a research partnership with AbbVie. Now the preclinical-stage biotech has raised $88.5 million for its own pipeline, including a drug that could offer advantages over a recently approved Amgen cancer therapy.

Cytokinetics stock soars on heart drug data that sets stage for Phase 3 studies

A Cytokinetics drug in development for treating a rare heart disorder has promising Phase 2 data suggesting it could compete against a Bristol Myers Squibb drug currently under FDA review. Cytokinetics plans to advance its small molecule to Phase 3 testing by the end of this year.

Erasca’s IPO leads the way as three cancer biotechs raise $534M for clinical trials

Cancer drug developer Erasca, whose mission is to “erase cancer,” has raised $300 million from its IPO. The clinical-stage biotech addresses a single elusive cancer target; it has multiple programs taking multiple approaches, two of them in human testing and the rest on track to join them.

INVEST Precision Medicine winner spotlight: Nia Therapeutics

The FDA has yet to approve a therapy for memory loss. Nia Therapeutics is developing a medical device that stimulates the brain to bring it back to a “good memory state,” and it was judged the winner in the life sciences track of the INVEST Precision Medicine Pitch Perfect Competition.

Wugen unveils $172M to take natural killer cell therapies to solid tumors

Wugen, a biotech developing “off-the-shelf” natural killer and CAR T cell therapies, has raised $172 million in Series B financing. The company’s lead program has already reached human testing and the new capital will be used to continue that research and advance other pipeline programs to the clinic.

PAQ Therapeutics scores $30M to unleash “Pac Man” drugs on neuro disease

Startup PAQ Therapeutics is developing drugs work like Pac Man, gobbling up components of a cell associated with disease. The biotech has closed $30 million in financing to continue its research, with a neurodegenerative disorder as its lead disease target.

Biogen reaches across globe and pays $125M to land its next new MS drug

By paying $125 million up front for rights to multiple sclerosis drug candidate orelabrutinib, Biogen secures a place among those companies trying to treat the disease by targeting a particular enzyme highly expressed in the central nervous system. But Biogen still has some catching up to do.

FDA update warns of potential rare nerve side effect for J&J Covid vaccine

The FDA is cautioning that the Johnson & Johnson Covid-19 vaccine may cause a rare immune response affecting the nerves. A causal link has not been established and the side effect, when observed, is rare, but the vaccine information has been updated to reflect the potential risk.

Bayer kidney disease drug gets FDA nod, pitting it against AstraZeneca, J&J meds

The FDA has approved Bayer’s Kerendia to treat chronic kidney disease in patients with type 2 diabetes. The drug is the first in its class, giving the pharma giant an alternative way to compete against medicines already marketed by AstraZeneca and Bayer.

Sigilon hemophilia A cell therapy trial placed on hold after patient complication

A hemophilia A patient in a Sigilon Therapeutics clinical trial developed a well-known complication to treatments for the blood disorder. The potential problem for Sigilon is that its cell therapy is designed to avoid triggering such immune responses.

Biotech startup using AI to take guesswork out of cancer drug selection raises $70M

Xilis is developing technology that creates a living model of a patient’s tumor, then applies artificial intelligence to determine the best drug or drug combinations to treat the cancer. Clinical trials are planned to test this precision medicine approach and the biotech startup has raised $70 million to fund its research.

Eli Lilly looks to startup Verge Genomics to turn AI analysis into new ALS drugs

Eli Lilly is partnering with startup Verge Genomics in a move intended to add ALS drugs to its neuroscience pipeline. To date, Verge’s artificial intelligence technology has produced programs internal programs in ALS, Parkinson’s, and frontotemporal dementia.

NeRRe nabs £20M to test chronic cough drug in patients with a fatal lung disease

A NeRRE Therapeutics drug that failed a clinical trial for refractory or unexplained chronic cough is getting a second shot as a potential treatment for chronic cough in patients with idiopathic pulmonary fibrosis, a rare lung disorder. The biotech raised £20M to proceed with Phase 2 testing.

How chatbots can help us beat Covid-19

Where chatbots really excel is in rapidly delivering reliable content in response to the recipient’s actual needs, questions, or concerns. That allows AI tools to serve as a bridge between vaccine manufacturers, regulators, public health officials, healthcare providers on the one hand and patients on the other.

Eli Lilly’s $15M investment deepens link to startup developing new class of RNA meds

Two months after Eli Lilly began an alliance with MiNA Therapeutics, a startup developing a new type of RNA therapy, the pharmaceutical giant is making a $15 million equity investment in its partner. MiNA is developing a new class of medicines called small activating RNA therapies.

CRO Parexel changes private equity hands again, this time for $8.5B

Four years after a private equity acquisition took Parexel private, the contract research organization is being acquired by two private equity firms for $8.5 billion. It’s the latest in a series of acquisitions to hit the CRO sector this year.

All in on amyloid, Acumen Pharma’s IPO raises $160M for Alzheimer’s drug R&D

Acumen Pharmaceuticals’ IPO raised $160 million to fund clinical development of its Alzheimer’s disease drug candidate. Though that drug goes after the same target as Biogen’s recently approved Aduhelm, Acumen says its antibody has potential dosing and safety advantages.

Apellis taps Beam’s base-editing tech to broaden autoimmune disease scope

Fresh off its first FDA approval, Apellis Pharmaceuticals is teaming up with Beam Therapeutics, a partnership that will use Beam’s base-editing technology to develop new therapies for complement system disorders. Apellis has committed to pay Beam $75 million to kick off the alliance.

Not yet in the clinic, Pardes Bio’s Covid-19 pill still fills in Foresite’s blank check

Pardes Biosciences advanced from concept to drug candidate in less than nine months. The preclinical biotech is developing an oral antiviral for Covid-19 and other coronavirus infections and it is going public in a SPAC merger that will infuse it with $276 million.

FDA rejection of rare disease drug leads Orphazyme to cut two thirds of staff

Orphazyme’s corporate restructuring comes less than two weeks after the FDA rejected arimoclomal, a drug developed to treat the rare Niemann-Pick disease type C. The company said it is now focused on securing regulatory approval in Europe and finding a path forward for the small molecule with the FDA.

Intellia’s early CRISPR trial data validate a drug pipeline and the gene-editing field

Intellia Therapeutics has early clinical trial data showing that its CRISPR-based therapy for a rare disease can edit genes inside the body safely and effectively. The trial is ongoing, but the preliminary results suggest that Intellia’s approach could offer a cure.

INVEST Pitch Perfect winner spotlight: Systems Oncology’s AI tech yields trove of cancer drugs

Systems Oncology has used its its artificial intelligence to discover small molecules in development under partnerships with large pharma companies. The R&D of the company, the biopharma startup winner in the Pitch Perfect contest at the recent MedCity News INVEST Conference, includes a new type of RNA drug.

Lyell, Verve IPOs raise a combined $692M as both biotechs steer toward clinical trials

Lyell Immunopharma and Verve Therapeutics are still preclinical, but they’re bring novel genetic approaches to the treatment of cancer and cardiovascular disease. Now the two companies can claim two of the biggest biotech IPOs of 2021 so far.

While Sage Therapeutics sees a window for depression drug, market is skeptical

A Sage Therapeutics depression drug that failed a pivotal study in 2019 has positive preliminary results from a new Phase 3 clinical trial, but the data also showed the therapy’s effects waned over time. Questions about zuranolone’s durability are relevant to Biogen, which committed $1.5 billion to Sage in large part due to the drug’s …

While Sage Therapeutics sees a window for depression drug, market is skeptical Read More »

 There is an urgent need for oral Covid-19 therapeutics as variants escalate

there is an urgent need to support the development of diverse and differentiated, multi-mechanistic and potentially complementary therapies, that are effective against Covid-19, are unaffected by the threat of viral mutation and, more critically than ever, are easy to make, distribute and take by the patient.  

ASCO 2021 recap: Lynparza’s lift, Grail goes on, LAG validation & more

The American Society of Clinical Oncology’ annual meeting featured news highlights from the Merck, Novartis, and other drug giants. Meanwhile, some small biotechs rode the coattails of their larger counterparts and others forged their own paths with promising early results for new cancer drug targets.

Precision medicine is growing fast. Can hospitals and clinicians can keep pace?

New technologies that enable precision medicine approaches to treating disease are reaching more patients. But panelists speaking at MedCity News’ INVEST Precision Medicine Conference added that advances in technology are happening faster than the ability of hospitals and health systems to keep pace.

Pioneering a new realm of biology, startup Senda Bio expands financing to $98M

Senda Biosciences is developing drugs based on an understanding of intersystems biology—the way that humans interact with bacteria and plants. The startup, founded by Flagship Pioneering, has added $55 million to advance its three lead programs to clinical testing next year.

AI-drug discovery biotech Valo Health is going public via a $2.8B SPAC merger

Valo Health is going public in a SPAC merger. Less than nine months removed from its formal launch, Valo is now revealing more about its artificial intelligence platform technology, which it plans to use to make the firm the first “digitally native” pharmaceutical company.

Merus eyes tumor-agnostic path for cancer drug addressing rare genetic target

Cancer drug developer Merus has encouraging early results indicating its drug can address several different types of tumors characterized by NRG1, a rare gene fusion. The company believes the data could support a regulatory filing for the bispecific antibody drug.

Versant Ventures unveils new startup that stabilizes proteins to treat disease

Stablix Therapeutics is developing technology that uses small molecules to stabilize a protein, keeping it from going to a cell’s built-in disposal system. The startup now has $63 million in funding to further invest in the technology and advance its first molecules toward the clinic.

FDA authorizes Regeneron’s Covid drug at lower dose, and in injectable formulation

Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans to seek full FDA approval of its antibody cocktail later this summer.

Novartis radiopharmaceutical improves survival in key prostate cancer study

Novartis reported Phase 3 study results for a targeted radiation therapy showing that treatment helped patients with advanced prostate cancer live longer. The company will present data from this pivotal study during the annual meeting of the American Society of Clinical Oncology.

Auris Medical pivots from hearing loss drugs, joins red hot RNA therapies field

Auris Medical has acquired Trasir Therapeutics, a startup developing technology that expands the delivery of RNA medicines to tissues beyond the liver. Going forward, Auris will sell or spin off its programs in hearing disorders and allergies and focus exclusively on RNA therapies.

Eying eczema, Amgen pays $400M to co-develop Phase 3-ready Kyowa Kirin drug

Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, a form of eczema. The deal comes months after Japan-based Kyowa Kirin reported positive preliminary Phase 2 data for its antibody.

If Big Pharma is from Mars and digital health startups from Venus, PharmStars wants to play Cupid

Digital health startups and pharma industry players sometimes don’t speak the same language, and the culture gap has led to failures in the past. A new accelerator focused on helping digital health companies engage better with pharma hopes to flip the script.

Amgen lands first FDA approval for drug targeting elusive mutation in lung cancer

FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded “undruggable” targets.

FDA authorizes Vir & GSK Covid-19 drug, introducing third antibody option

FDA authorization of the Covid-19 antibody drug from Vir Biotechnology and GlaxoSmithKline adds a third antibody drug for treating early cases of the disease that are at risk of progressing to hospitalization. The companies say they plan to launch the drug, named sotrovimab, “in coming weeks.”

Engine Biosciences revs up $43M for AI tech that yields targeted cancer therapies

Engine Biosciences closed a $43 million Series A financing that the startup will apply to its artificial intelligence-based technology for drug discovery. The company analyzes genetic interactions, “deciphering biology” to find new cancer drugs.

IQVIA adds to growing lab biz with $198M deal for Myriad contract services unit

IQVIA is paying nearly $200 million to purchase a Myriad Genetics subsidiary that provides pharmaceutical contract services , a deal that will put the new acquisition in the company’s Q2 Solutions unit, The deal follows IQVIA’s April announcement that it had secured full ownership of Q2, which had been a joint venture with Quest Diagnostics.

Moderna’s Covid vaccine shows efficacy in younger teens; regulatory filing are next

Moderna released preliminary clinical data showing its Covid-19 vaccine produced efficacy in adolescents that was comparable to what was seen in adults. The company plans to submit applications to regulators in early June seeking expansion of emergency authorization of the vaccine to include this younger age group.

NGM Bio’s NASH drug fails in Phase 2; focus shifts to Merck-partnered programs

An NGM Biopharmaceuticals drug candidate for the fatty liver disease NASH failed a Phase 2b study less than a year after the company reported positive results from an earlier mid-stage study. The biotech will now focus on programs in eye diseases and cancer that are partnered with Merck.

FDA approval of J&J drug is first for lung cancer with particular genetic mutation

Johnson & Johnson subsidiary Janssen was awarded approval for Rybrevant, the latest in a string of decisions for targeted therapies for non-small cell lung cancer. Rybrevant is the first approved targeted therapy addressing a subset of patients whose disease is characterized by a particular mutation to cancer protein EGFR.

CVS joins the decentralized clinical trials movement with launch of new biz unit

CVS has launched a new clinical trials services business that will help drug companies and contract research organizations recruit clinical trial volunteers. The new business unit builds on work the pharmacy giant did last year, identifying and recruiting recruit people for clinical trials testing Covid-vaccines and medicines.

Biogen teams up with Ginkgo Bioworks in gene therapy manufacturing pact

Biogen is reaching across the Charles River, striking up a gene therapy manufacturing alliance with synthetic biology firm Ginkgo Bioworks. Ginkgo will use its technology to accelerate and make more efficient the process of manufacturing the AAV viral vectors used in gene therapies.

Eli Lilly looks ahead to FDA after diabetes drug wraps up last clinical test

Eli Lilly diabetes drug tirzepatide beat long-acting insulin in the last of a series of global studies designed to support regulatory submissions for the type 2 diabetes drug, a potential successor to blockbuster drug Trulicity. The Indianapolis-based drug giant said it expects to file for approval by the end of 2021.

Bristol Myers “dual immunotherapy” beats Opdivo alone in melanoma study

Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping melanoma from progressing. BMS will present the data at the upcoming annual meeting of the American Society of Clinical Oncology.

Bayer’s BlueRock Therapeutics widens cell therapy scope to the eye under new pact

BlueRock Therapeutics, a Bayer subsidiary, is teaming up with Opsis Therapeutics and Fujifilm Cellular Dynamics in an R&D pact focused on developing stem cell therapies for eye diseases. BlueRock is paying its new partners $30 million up front to kick off the alliance.

Bristol Myers writes $200M check for rights to Agenus checkpoint inhibitor

Bristol Myers Squibb already has a cancer program targeting the TIGIT protein, but in acquiring rights to Agenus’s drug, the pharma giant adds a bispecific antibody that preclinical research suggests has the potential to be the best in this drug class. BMS agreed to pay $200 million up front for global rights.

With FDA approval, Apellis can challenge AstraZeneca in rare blood disorder

The FDA approved Apellis Pharmaceuticals drug pegcetacoplan (Empaveli) as a treatment for a rare blood disorder that is currently treated with medicines sold by Alexion Pharmaceuticals, a biotech being acquired by AstraZeneca. But Apellis’s drug beat Alexion drug Soliris in a head-to-head test, and the smaller company aims to steal market share from its larger …

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Sanofi & GSK Covid-19 vaccine posts strong clinical data, paves way for Phase 3

Sanofi and GlaxoSmithKline reported positive preliminary Phase 2 data for their Covid-19 vaccine. Though several vaccines have been authorized, the companies say that their vaccine’s foundation in existing influenza vaccines offers advantages, and potentially gives their candidate a place in the market as a booster shot.

Backed by $92M, startup Interline aims to shed new light on protein communities

Interline Therapeutics has technology that shows how proteins interact as communities, paving the way for the discovery of new drugs. CEO Zachary Sweeney, a Denali Therapeutics veteran, said the startup will use the $92 million in funding to advance programs in cancer and inflammatory diseases.

Heron Therapeutics’ combo drug for post-surgical pain wins FDA nod on third try

Heron Therapeutics is positioning its drug, Zynrelef, as a way to help patients avoid addictive opioid painkillers following surgery. The extended-release formulation offers analgesic effects over 72 hours—when postsurgical pain is most severe and more likely to require pain management medication.

Biogen adds to neuro drug pipeline with acquisition of stroke drug from TMS

Biogen paid $18 million to acquire a drug that TMS Co. of Japan tested in patients with acute ischemic stroke. The acquisition follows the report of preliminary mid-stage data showing the drug led to no cases of a potentially fatal complication associated with currently available stroke therapies.

Perceptive Advisors closes $515M fund to fuel more early-stage biotech startups

Perceptive Advisors has $515 million for its second fund investing in biotech startups. Portfolio Manager Chris Garabedian says Perceptive Xontogeny Ventures Fund II is looking to make Series A investments in early-stage companies with assets that can show a path to clinical testing.

Talaris Therapeutics’ IPO raises $150M to transform solid organ transplants

Three biotechs IPOs priced this week while one gene therapy developer postponed its plans. The biggest IPO belongs to Talaris Therapeutics, a company developing a cell therapy for organ transplant patients that could mean the end of lifelong immunosuppressive drugs that prevent rejection.

Andreessen Horowitz leads $100M Series A round in Dyno and its gene therapy tech

Dyno Therapeutics’ technology for designing viral vectors that deliver gene therapies has led to partnerships with Novartis, Sarepta Therapeutics, and Roche. With the Series A financing, the startup plans to expand its technology to address more tissue types, and potentially add more partners.

Neuroelectrics gets $17M for new take on electrical therapy for epilepsy, depression

Neuroelectrics is planning a pivotal test of its wearable medical device, which delivers brain electrical stimulation to treat epilepsy. The startup’s Series A round of funding was led by Morningside Ventures.

Roivant’s move to go public reveals just how much its drug strategy has changed

Founded by former hedge fund manager Vivek Ramawamy, Roivant Sciences set out to redefine drug development by acquiring overlooked drugs and advancing their development. The merger deal that will take it public reveals how much new technology changed the company’s vision and its strategy.

Gene therapy funding frenzy reaches Affinia as it reels in $110M in new capital

Affinia Therapeutics, which has technology that could deliver gene therapies to more tissue types in the body, raised the Series B financing as it looks ahead to clinical testing. The biotech is the latest company to close a substantial round of funding for gene therapy technology.

Capsida unveils $140M, AbbVie alliance & tech that takes gene therapy to the brain

Capsida Biotherapeutics’ technology can engineer viral vectors that deliver gene therapies to central nervous system cells. With that capability gave the startup was able to raise $50 million in Series A financing and a multi-drug research alliance AbbVie.

Biotech IPO wave rolls on as Werewolf, Vaccitech raise $230M for clinical trials

Vaccitech and Werewolf Therapeutics joined the public markets, raising a combined $230 million. The vaccine developer and the cancer immunotherapy biotech will apply the IPO proceeds toward clinical development of their respective pipelines.

Adverum Bio’s shares plummet after patient in gene therapy study loses vision

Adverum Biotechnologies reported that a diabetic macular edema patient treated with the biotech’s experimental gene therapy developed complications, including blindness, in the treated eye. The company has unmasked the study and is trying to identify potential risks to other patients.

Startup Boundless Bio brings in $105M to break the circle behind cancer growth

Boundless Bio’s research has uncovered a previously unknown driver of cancer growth and drug resistance. With $105 million in Series B financing, the biotech is on a path to bring to the clinic small molecules that address this target, called extrachromosomal DNA.

No more tears: Aldeyra’s eye drug data support its allergy treatment alternative

Seasonal allergy sufferers have a plethora of choices for treating the itching and redness affecting their eyes. An experimental Aldeyra Therapeutics drug that takes a new approach to blocking inflammation triggered by allergens has met the goals of a pivotal study and the biotech now plans to discuss the data with the FDA.

FDA lifts clinical hold, clearing uniQure to resume hemophilia gene therapy trial

A uniQure gene therapy for hemophilia B that has been under a clinical hold for four months can now resume testing. The hold was lifted after uniQure answered the FDA’s questions about whether the gene therapy caused the liver cancer diagnosed in one patient who received the therapy.

FDA approves ADC Therapeutics antibody drug conjugate in B-cell lymphoma

With FDA approval of Zynlonta, ADC Therapeutics can offer patients who have diffuse large B-cell lymphoma an option if CAR-T therapy doesn’t work. Additional clinical trials are underway that could expand use of the antibody drug conjugate to more cancer patients.

Alnylam FDA submission aims to expand biotech’s franchise of gene-silencing drugs

Alnylam Pharmaceuticals has filed for FDA approval of vutrisiran, which could become the biotech’s fourth drug that works by RNA interference. Meanwhile the company is responding to a federal subpoena seeking documents related to the company’s marketing and promotion of its first RNAi drug, Onpattro.

Covid-19 serves as catalyst for effort to diversify clinical trial enrollment

Covid-19 showed how technology can upend the old ways of clinical trials. Panelists at MedCity’s INVEST conference said it’s highlighting the importance of improving clinical trial diversity so that tests of new therapies and vaccines reflect the population of patients that they will treat in the real world.

Biotech and medical device companies raise $913M in a five-IPO week

The five life sciences IPOs this week continues the steady march companies are making to the public markets this year. This week’s activity follows a first quarter that Renaissance Capital calculates was the busiest for newly public companies since 2000. Healthcare IPOs continued to dominate the stock offerings.

Like it or not, value-based contracting is coming for drugs and medical devices

Value-based contracts covering the reimbursement of drugs and medical devices are slowly gaining acceptance. A panel at the MedCity News INVEST conference discussed the challenges and opportunities for these contracts, which aim to improve patient outcomes and control the cost of care.

Vertex Pharma inks another R&D alliance to expand its gene-editing ambitions

Vertex Pharmaceuticals is collaborating with Obsidian Therapeutics to develop up to five new gene editing therapies. Obsidian’s technology precisely controls protein expression, a capability the partners plan to apply to several undisclosed serious diseases.

Regulatory progress for two biotechs stalls as FDA requests more information

The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has some questions about the historical data Y-mAbs used as the control in a clinical trial for its antibody cancer drug.

Vertex to pay CRISPR Therapeutics $900M for bigger share of gene-editing alliance

Vertex Pharmaceuticals is amending its collaboration with CRISPR Therapeutics, paying $900 million now for chance to grab a bigger share of a gene-editing therapy’s profits later—if the treatment is approved. Clinical trials evaluating the CRISPR-based therapy are underway in sickle cell disease and beta thalassemia.

Adagio adds $336M for pivotal tests of drug with potential to beat Covid variants

Antibody therapies are seen as one way to overcome the variants that continue to fuel the pandemic. With its Series C financing, Adagio Therapeutics, led by CEO Tillman Gerngross, will proceed with a pivotal clinical trial of an antibody that has neutralized SARS-CoV-2 variants in lab and animal tests.

OrbiMed-incubated Theseus unveils $100M to beat cancer drug resistance

Incubated by OribMed and led by Ariad Pharmaceuticals veterans, Theseus Pharmaceuticals unveiled $100 million in Series B financing to develop the next generation of tyrosine kinase inhibitors, a type of cancer drug. The company expects to enter the clinic by the end of 2021.

Relay Therapeutics pays $85M for startup with a new AI tech for drug discovery

Relay Therapeutics has its own technology that applies artificial intelligence and machine learning techniques to drug discovery. Its $85 million acquisition of ZebiAI gives it another technology that applies ML to DNA-encoded libraries and predicts the small molecules with the potential to drug proteins.

Merck’s Covid-19 drug R&D falls short twice in treating hospitalized patients

Merck is discontinuing work on one Covid-19 drug for treating hospitalized patients after the FDA said it needs more clinical data. Another Merck drug candidate is moving forward only in outpatient testing after independent clinical trial observers concluded the antiviral was unlikely to help those in the hospital.

Thermo Fisher’s $21B deal for PPD gives it missing piece in drug development cycle

Thermo Fisher Scientific sells laboratory equipment used in drug research and it also offers manufacturing services for experimental and commercialized drugs. By acquiring PPD, Thermo Fisher says it will gain capabilities in the growing global market of clinical trial services.

Amylyx Pharma’s ALS drug needs a Phase 3 study to support FDA submission

Amylyx’s ALS drug met the goals of a mid-stage study, paving the way for regulatory submissions in Europe and Canada. But the FDA is requiring data from a larger Phase 3 clinical trial and that study is slated to begin later this year.

FDA & CDC “pause” J&J Covid-19 vaccine to launch inquiry into rare blood clot cases

Blood clots found in six people given Johnson & Johnson’s Covid-19 vaccine have led federal health officials to recommend a pause on dosing with that shot. A CDC advisory committee on vaccine practices is meeting Wednesday to review the cases, which so appear similar cases observed in Europe with AstraZeneca’s vaccine.

Biotech startup Repertoire adds $189M to expand array of immune medicines

With two cancer programs already making progress, Repertoire Immune Medicines will use the Series B financing to expand its immune synapse research to autoimmune disorders and infectious disease. CEO John Cox said his startup’s approach could advance immune medicines beyond the scope of currently available therapies.

Covid-19 was a lightning rod for life science deals last year. What investment trends are taking shape in 2021? [Sponsored]

Peter Meath, Co-Head of Healthcare and Life Sciences for Middle Market Commercial Banking at J.P. Morgan, is bullish that the momentum will continue, particularly with investment trends focused on pain points amplified by the Covid-19 pandemic, from diagnostics development to supply chain management.

Regeneron, Roche injectable antibody drug shows efficacy in preventing Covid-19

A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug developer, along with partner Roche, plan to ask regulators to expand the drug’s authorization to include disease prevention.

How eConsent empowers more participant engagement in clinical trials

Creating the simplest process for informed consent benefits the potential participant by allowing them the time and resources to understand fully what they are consenting to. Through eConsent processes, research also opens the door to a more diverse population to engage in trials.

Ventus Therapeutics tacks on $100M to take on ‘undruggable’ disease targets

RA Capital led Ventus Therapeutics’ Series B financing, which the startup will use to develop its pipeline of medicines for “undruggable” disease targets. CEO Marcelo Bigal said the cash also gives Ventus the flexibility to consider an IPO.

Hologic makes a multiplex molecular testing move with $795M Mobidiag acquisition

Mobidiag offers multiplex testing, which is the ability to test for multiple pathogens from a single test sample. Hologic said the acquisition will enable the company to enter the acute care test market, which is projected to grow in a post-pandemic world.

Icosavax lands $100M to take its virus-like particle vaccines into clinical trials

RA Capital led the $100 million Series B round of funding for Icosavax, a startup developing vaccines based on virus-like particles. The biotech is preparing for clinical tests of vaccines for respiratory syncytial virus, human metapneumovirus, and SARS-CoV-2.

Supernus ADHD drug is FDA approved; first new ‘non-stimulant’ med in a decade

FDA approval of Supernus Pharmaceuticals drug Qelbree gives attention-deficit hyperactivity disorder patients another treatment option that is not classified as a Schedule II substance. It’s a different formulation of a drug that was first approved in Europe decades ago.

FDA rejects Acadia’s bid for Nuplazid approval in dementia-related psychosis

The FDA’s rejection of Nuplazid cited clinical trial results in subgroups of patients. Acadia Pharmaceuticals said the FDA’s decision goes against all feedback the company previously received and amounts to an incorrect way of evaluating dementia patients.

Helius Medical’s device gets FDA all clear to stimulate the brain via the tongue

A Helius Medical Technologies medical device that stimulates the brain by sending electrical stimulation to the tongue has received FDA clearance for multiple sclerosis patients. The company says its approach could also have applications in other disorders.

IQVIA pays Quest Diagnostics $760M to get full control of central lab joint venture

IQVIA has acquired Quest Diagnostics’ minority stake in Q2 Solutions, a central laboratory services joint venture the two companies formed in 2015. But Quest will remain a preferred provider of lab testing services under an agreement with Q2.

United Therapeutics notches another FDA approval for lung drug

The FDA decision for Tyvaso as a treatment for pulmonary arterial hypertension in patients who have interstitial lung disease is the second approval for the United Therapeutics drug. The additional indication gives the company another way to grow revenue for the drug, which faces generic competition.

Achilles Therapeutics’ IPO nabs $175M to bring cell therapies to solid tumors

The Achilles Therapeutics IPO comes as several other biotechs make progress developing a type of cancer immunotherapy called a tumor-infiltrating lymphocyte. Clinical-stage Achilles contends its approach could best them all.

Pfizer & BioNTech report Covid-19 vaccine shows 100% efficacy in kids 12 to 15

Based on the efficacy and safety data for their Covid-19 vaccine in younger teens, Pfizer and BioNTech plan to ask regulators to expand emergency authorization to include this younger group. The expansion could make the mRNA vaccine available to this age group in time for the coming school year.

Regenerative medicine is already changing the way drugs are discovered and tested

Regenerative medicine might someday provide replacement organs for transplant patients. But Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, explained how the technology is already helping in the discovery and testing of drugs.

Leyden Labs unveils €40M for medicines that could prevent Covid-19 & more

Founded by scientists behind the technology used in Johnson & Johnson’s Covid-19 vaccine, Leyden Laboratories is developing intranasal medicines intended to stop viruses before they infect the lungs. SARs-CoV-2 is one target, but the startup plans to address many respiratory pathogens.

The “biggest thorn in President Trump’s side” is now HHS Secretary. What’s next?

California Attorney General Xavier Becerra may have won a narrow confirmation to be the Department of Health and Human Services Secretary, but if his past is any indication, his agenda will be bold when it comes to reining in pharma companies, boosting the Affordable Care Act and scrutinizing hospital consolidation.

In MedCity Pivot podcast, biopharma researcher talks about protein degradation, recent success tied to Covid-19 [Sponsored]

Ho Sung Cho, senior vice president of Biodiscovery Therapeutics at Bristol Myers Squibb, talks about lessons learned from drug discovery, recent success tied to Covid-19, and how the company is leveraging its expertise in protein degradation to develop novel therapies for blood cancers, solid tumors and other important therapeutic areas.

ProQR’s RNA therapy on track to pivotal tests in rare, inherited form of vision loss

ProQR Therapeutics has encouraging data from an early-stage study evaluating its treatment for vision loss in the rare, inherited disorder Usher syndrome. The biotech now plans to advance its RNA therapy to two pivotal studies later this year.

AstraZeneca’s Covid-19 vaccine data may have ‘outdated information,’ NIH cautions

Federal health authorities say safety observers are concerned AstraZeneca did not release complete information about the efficacy of its Covid-18 vaccine. The company responded by saying its data were from a pre-specified analysis and it will provide the most up to date efficacy data within 48 hours.