Category: biopharma nl
Chief scientist on Operation Warp Speed resigns
The fight against Sars-CoV-2 in 2021: What’s next?
Biotech startup raises $25M for cancer, Covid-19 vaccines
Treating cancer with precision: It’s time for host response rofiling
One year after founding, startup EQRx raises $500M to advance goal of cheaper cancer drugs
Key takeaways from BioNTech CEO’s JPM presentation
Next-gen antibody tests promise more answers to Covid-19 questions
Can we warp-speed antibiotic development?
Armed with $270M in capital, Scorpion Therapeutics aims to broaden the reach of precision oncology
FDA flags false negatives in startup’s Covid-19 test
Are metabolic hormones the next frontier in cancer treatment?
Trial results extend add to uses for Exact Sciences test
What if we captured the spirit and urgency of Covid-19 research to cure cancer?
Predictions for AI-powered digital healthcare in 2021
FDA gives nod to Moderna vaccine for Covid-19
Beckman Coulter seeks authorization for $4 antigen test
Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19
4 takeaways from FDA’s emergency vaccine reviews
Hospitals sue drug companies over discount program
The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person picked to head the department under the incoming Biden administration.
Immunai joins 10x Genomics program to boost drug development
Is the biopharma industry right to be skeptical about AI?
How augmented intelligence and NLP can help clinicians, researchers identify rare diseases
To help clinicians diagnose rare disease more quickly and accurately, many healthcare organizations are embracing technology solutions like natural language processing (NLP) tools that can create augmented intelligence workflows that facilitate the rapid search of unstructured clinical data from multiple data sources.
Covid-19 is bringing digital therapeutics to the forefront of medicine
FDA gives emergency OK to Pfizer and BioNTech vaccine
Getting the right data to doctors is next hurdle for precision medicine
FDA panel backs use of Pfizer/BioNTech vaccine for Covid-19
AI offers promise but faces barriers in drug development
A proliferation of genetic testing options brings new challenges
Digital pathology startup Proscia lands $23M to advance software platform
Level Ex pitches gaming as a tool for reaching doctors
MedCity News Spotlight: How CancerIQ is advancing precision medicine
Innovation, not price controls, will ensure patients’ ongoing access to life-saving medicines
Covid-19 Is derailing cancer clinical trials. Is new technology required to get them back on track?
Introducing Healthcare Docket: Reporting on the intersection of healthcare and law
Rising drug costs fuel interest in value-based contracts
The contracts are complicated and full of risks for drug companies. But there’s also a risk to steering clear of the arrangements — reduced or restricted access to a company’s medication.
Accumulated genetic variations: What they are and why they matter to a complete health picture
Unlike inherited genetic predispositions, accumulated genetic changes are the result of environmental influences, such as smoking, chemicals or ultra-violet radiation. A growing body of research links somatic changes to an increased likelihood of blood cancers and cardiovascular disease, both heart disease and stroke.
Rethinking pharma CRM: It’s not just for sales anymore [Sponsored]
INVEST 2021 Pitch Perfect contest now open to receive startup applications
MedCity Pivot Podcast: Sight Diagnostic’s exec talks about using computer vision in blood diagnostics
Investors pour $91M into growing clinical-trial software firm
New study ties pharma payments to prescription practices
Opioid overdoses are spiking amid the pandemic – PBMs can help combat opioid abuse and misuse
Mark your calendars for our virtual INVEST Precision Medicine conference, December 9-11
AstraZeneca, Oxford are latest to unveil Covid-10 vaccine results
Imago raises $80M to further studies of its treatment for blood and bone-marrow disorders
Lucira Covid-19 test is first to get FDA nod for home use
Why contract development and manufacturing for radiopharma may be a smart move
Moderna does one better than Pfizer/BioNTech; touts 94.5% efficacy for its Covid vaccine
Important questions about Pfizer’s Covid-19 vaccine
News of positive results from Pfizer’s Covid-19 vaccine is heartening but historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.
With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race
FDA advisory panel vote against approving Biogen’s drug for Alzheimer’s
What the U.S. needs to do to assist cancer patients and their physicians in developing countries
More than human: Taking healthcare back to its people-centered roots
Merck paying $2.75B for cancer therapeutics firm VelosBio
Culture-free alternatives for characterizing bloodstream infections
Survey: A third of states weighing moves to spend less on drugs
Gains in tRNAslation: It’s time for investors to realize the potential of European RNA technologies
To avoid crisis, pharma must address costs
7 best practices for pharmacies managing short-dated inventory
Why prioritizing health equity in the Covid-19 vaccine distribution is not just right, but necessary
Swiss startup betting on nanotechnology to speed cancer diagnosis
Bayer paying up to $4B for gene therapy pioneer AskBio
Startup focused on B-cell therapies launched with $52M in Series A
Landmark FDA approval of antiviral drug as 1st COVID-19 treatment comes amid conflicting efficacy data
Covid-19’s digital imperative for biopharma and medtech [Sponsored]
Will Covid-19 be the straw that breaks AI’s back?
AI drug-discovery firm lands first partnership
The deal with Roche subsidiary Genentech is likely not the last for Genesis Therapeutics, which is based on AI research undertaken at Stanford. Such partnerships are potentially lucrative for drug-discovery startups.
At HLTH, FDA chief reiterates that vaccine approvals will be evidence-based
Seattle Genetics rebrands as Seagen as it expands business globally
Takeda strikes $1B RNAi deal with Arrowhead Pharmaceuticals
The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.
CRISPR gene-editing discoverers awarded Nobel Prize in chemistry
The prize went to Jennifer Doudna of the University of California Berkeley and Emmanuelle Charpentier of the Max Planck Institute. Charpentier published her research on the biology behind the technology in 2011 and collaborated with Doudna. The two discovered it was possible to control the mechanism.
Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data
The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016 next month.
FDA issues Covid-19 vaccine guidance as White House reportedly relents
The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.
Amgen announces ‘positive’ Phase II lung cancer results for cancer drug with hard-to-reach target
BMS acquires MyoKardia, maker of drugs for cardiovascular disease, for $13.1B
MD Anderson researchers find mechanisms behind CAR-T cells’ efficacy, toxicity
Amid mixed messages about his Covid-19 diagnosis, Trump looks like a one-man clinical trial
Gilead takes over distribution of Covid-19 antiviral drug from federal government
Ovid drug reduces seizure frequency in two rare forms of epilepsy, according to early Phase II data
Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study
Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data
Regeneron to go to regulators with Covid-19 drug on results in outpatients
AI-centered drug discovery startup XtalPi raises nearly $319M in Series C round
Policy makers should ‘set their sights higher’ on U.S. drug pricing regulations, researchers say
Triumvira Immunologics raises $55M in Series A funding round for new form of cancer cell therapy
Foundation Medicine to launch liquid biopsy companion diagnostic following FDA approval
Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M
The charges, filed in Philadelphia federal court, allege that Teva conspired with four other generic drug companies to fix prices, rig bids and allocate customers. Teva – which the Justice Department and New York’s state government also sued this month for unrelated allegations – said it rejected the allegations.
AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19
The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar to that of Regeneron and Roche with their drug, REGN-COV2.
Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting
Aetion completes $82M Series B round with $19M extension
J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]
In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has transformed the way people usually do business in the sector.
Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.
Moderna to supply up to 160M doses of Covid-19 vaccine to Europe
FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy
While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science and data alone – may have played a role.
Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19
Pfizer, Germany’s BioNTech release new data on Covid-19 vaccine
Astellas’ Audentes Therapeutics discloses third patient death in gene therapy trial
Report: FDA halted move to authorize convalescent plasma for Covid-19 over evidence concerns
J&J to buy Momenta Pharmaceuticals for $6.5B
FDA rejects BioMarin’s hemophilia A gene therapy in ‘massive surprise’
FDA issues surprise rejection of Gilead, Galapagos rheumatoid arthritis drug
Regeneron, Roche team up in global deal on Covid-19 antibody cocktail
Gilead invests another $145M into expanded oncology pact with Tango Therapeutics
Purdue Pharma accused of causing $2.2T in damages amid opioid epidemic
Founders’ story: Pleiogenix
FDA approves Roche drug for rare autoimmune disorder NMOSD
Sanofi to acquire Principia Biopharma for $3.7B
Interest in rapid Covid-19 antigen tests continues despite accuracy concerns
BMS puts $300M toward diversity efforts, including clinical trial diversity
Gilead got a boost from a newly approved PrEP drug. Now, a major insurer is dropping coverage
Trials of Gilead’s remdesivir in Covid-19 not diverse enough, experts write
Reify raises $30M in Series B round for clinical trial cloud computing system
Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine
Bayer to acquire KaNDy Therapeutics in $875M women’s health play
Report: Russia says its Covid-19 vaccine ready for market despite no Phase III data
FDA approves Roche, PTC drug for spinal muscular atrophy
Guardant scores FDA approval for liquid biopsy test
StartUPDATES: New developments from healthcare startups
Big Pharma plays CMO as Pfizer signs on to produce Covid-19 drug remdesivir for Gilead
Biogen to get speedy FDA review for Alzheimer’s drug despite not using voucher to request it
GSK nabs FDA approval for first-in-class multiple myeloma drug
How the biotech capital markets are faring in the time of Covid-19
Why hydroxychloroquine’s appeal endures despite evidence it doesn’t work for Covid-19
Novartis plans to seek approval for CAR-T in slow-growing lymphoma after Phase II success
J&J in $1B supply pact with federal government for one-shot Covid-19 vaccine
Sight Diagnostics raises another $71M to fully commercialize its blood analyzer
Merck, Hanmi sign $870M deal for NASH drug
INVEST Pitch Perfect winner spotlight: Amplified Sciences targets early pancreatic cancer detection
Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients
INVEST Pitch Perfect winner spotlight: Pleiogenix eyes road ahead for liver disease drug
FDA approves MorphoSys, Incyte’s drug for vulnerable lymphoma population
Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan
Sanofi, GSK nab $2.1B deal from federal government to provide Covid-19 vaccine
Delivering on the promise of precision cancer medicine and why it matters even more during a pandemic
Alexion drops kidney disease program for drug that was part of $930M Achillion buyout last year
BMS, bluebird refile FDA approval application for CAR-T therapy in myeloma
Phase III study of Roche anti-inflammatory drug in Covid-19 fails
Thrive raises $257M Series B round for registration study of blood test for early cancer detection
AI algorithm for detecting prostate cancer shows more than 98% sensitivity, 97% specificity in study
Pfizer, BioNTech start late-stage study of Covid-19 vaccine
AstraZeneca, Daiichi Sankyo sign $6B deal for antibody-drug conjugate
Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial
Hydroxychloroquine flunks Phase III trial in mild-to-moderate Covid-19
Gilead’s Kite Pharma gets FDA nod for second CAR-T cell therapy
Go to war with the army you have: Until there’s a vaccine, a cocktail can fight Covid-19
French biotech Genfit shifts gears after Phase III NASH failure
Access Bio gets FDA emergency authorization for quick Covid-19 test
Chugai, Biofourmis partner on DTx for pain monitoring
How can life science companies benefit from hiring a Professional Employer Organization? [Sponsored]
Biogen to launch Phase IV study of spinal muscular atrophy drug in post-gene therapy patients
Synairgen says inhaled biologic lowered risk of Covid-19 worsening in hospitalized patients
AstraZeneca Covid-19 vaccine shows antibody levels comparable to recovered patients
FDA guidance eases some Covid-19 vaccine concerns, but others remain
Russian hackers suspected in Covid-19 vaccine intellectual property theft, report says
Relay Therapeutics prices IPO at $400M
Physical therapy can create a path for reduced opioid use
Moderna publishes Phase 1 Covid-19 vaccine data showing robust immune responses
Glympse Bio raises more than $46M in Series B round for biosensor technology
FDA AdCom votes unanimously in favor of GSK myeloma drug, despite earlier agency skepticism
Roche pays Blueprint $675M upfront for ex-U.S. development, commercialization rights to cancer drug
Pfizer, BioNTech get fast-track from FDA for Covid-19 vaccines
Gilead starts Phase I trial of inhaled version of Covid-19 drug remdesivir
FDA raises concerns over ocular toxicity from GSK’s potential first-in-class myeloma drug
Gilead Covid-19 drug remdesivir benefited from $6.5B in NIH-funded basic research, study finds
Moderna completes enrollment in Phase II Covid-19 vaccine trial
MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron
Bari Kowal, vice president of global clinical operations at Regeneron Pharmaceuticals, gives an update on the clinical trials ongoing to develop drugs to fight Covid-19 and provides insights on how the clinical trials landscape and pharma overall must change in the next episode of MedCity Pivot Podcast.
VelosBio raises $137M Series B round to support suite of ROR1-targeting cancer drugs
Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.
The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug’s clinical benefit.