Sickle cell disease research is seeing a flurry of activity with several companies currently testing therapies for the genetic blood disorder and one company recently receiving FDA approval. Imara aims to set itself apart from the pack and it is preparing to go public to support continued clinical development of its own sickle cell drug. … Continue reading “Imara Reveals IPO Plan as Sickle Cell Drug Advances in the Clinic”
Category: National
New Meds Set to Reshape US CNS and Oncology Markets
CNS and cancer will be biopharma battlegrounds this year according to Philadelphia-based Clarivate Analytics, which says new medicines will reshape the US market. The US Food and Drug Administration (FDA) looks set to approve several innovative therapies for central nervous system (CNS) disorders and cancer in 2020, according to Clarivate (NYSE: [[ticker:CCC]]). The firm cited … Continue reading “New Meds Set to Reshape US CNS and Oncology Markets”
Agile Therapeutics Wins FDA Nod for Twirla Contraceptive Patch
A contraceptive patch developed by Agile Therapeutics was awarded FDA approval late Friday, clearing the way for a new birth control option to reach the market. The Agile (NASDAQ: [[ticker:AGRX]]) product, called Twirla, deliver delivers a combination of hormones via a proprietary skin patch applied once a week. It’s the first FDA approved product for the … Continue reading “Agile Therapeutics Wins FDA Nod for Twirla Contraceptive Patch”
Bio Roundup: Goodbye Belviq, LogicBio on Hold, Revolution’s IPO & More
Drugs typically go through three phases of clinical testing to support an application for FDA approval. It’s easy to overlook Phase 4, which takes place after a drug reaches the market. Post-marketing studies aim to identify side effects not observed in the first three phases of testing. They also evaluate how a therapy works over … Continue reading “Bio Roundup: Goodbye Belviq, LogicBio on Hold, Revolution’s IPO & More”
Eisai Pulls Weight Loss Drug From Market After FDA Flags Cancer Risks
Eisai is withdrawing weight-loss drug lorcaserin after a post-marketing study found a higher incidence of cancer in patients who took the medicine. The FDA said Thursday that its request for removal of the product from the market is voluntary, but Eisai has already started the process for doing so. The withdrawal follows an FDA alert … Continue reading “Eisai Pulls Weight Loss Drug From Market After FDA Flags Cancer Risks”
Revolution Medicines IPO Reels In $238M to Take On RAS in Cancer
The RAS family of proteins is one of the hottest targets in cancer research despite being one of the hardest for drug hunters to hit. Revolution Medicines has raised $238 million in an IPO to finance development of therapies that it says can drug these molecules in a novel way. On Wednesday evening, Revolution priced … Continue reading “Revolution Medicines IPO Reels In $238M to Take On RAS in Cancer”
Ligand’s Icagen Deal Brings Neuro, CF Assets Plus Partnering Potential
Ligand Pharmaceuticals is adding neurological disease and cystic fibrosis programs to its pipeline through a deal to acquire assets from drug discovery company Icagen. San Diego-based Ligand (NASDAQ: [[ticker:LGND]]) is paying $15 million up front for the “core assets” of Icagen’s Durham, NC operations. The neuroscience program is being developed under a partnership with Roche … Continue reading “Ligand’s Icagen Deal Brings Neuro, CF Assets Plus Partnering Potential”
CRISPR, CAR-T, Consolidation: Top Advanced Therapy Milestones of 2019
CRISPR, capacity, and consolidation powered the cell and gene therapy space in 2019, but a proactive focus on patient access topped Falcon Therapeutics CEO Susan Nichols’ annual roundup. In what has become one of the most anticipated presentations at the Phacilitate Leaders World Conference, Susan Nichols, CEO of private North Carolina-based cell therapy firm Falcon … Continue reading “CRISPR, CAR-T, Consolidation: Top Advanced Therapy Milestones of 2019”
Two Big Pharma Alliances End in Nixed Deals. Here’s What Happened.
Pfizer and Merck are each cutting ties with a smaller clinical-stage biotech after experimental drugs being developed under separate alliances fell short in human testing. Pfizer (NYSE: [[ticker:PFE]]) is walking away from a partnership with GlycoMimetics (NASDAQ: [[ticker:GLYC]]) a Rockville, MD-based company developing drugs for diseases where carbohydrates play a role. In 2011, Pfizer paid … Continue reading “Two Big Pharma Alliances End in Nixed Deals. Here’s What Happened.”
FDA Clinical Hold Stops LogicBio’s Gene Editing Study Before It Starts
The FDA has placed a clinical hold on a LogicBio Therapeutics application to begin human testing of its experimental gene-editing therapy for a rare, inherited liver disorder. LogicBio (NASDAQ: [[ticker:LOGC]]) disclosed the clinical hold for its gene-editing therapy, LB-001, after Monday’s market close. The Cambridge, MA-based biotech said that the hold concerns “certain clinical and … Continue reading “FDA Clinical Hold Stops LogicBio’s Gene Editing Study Before It Starts”
Wave Life Sciences’ Stumble in Duchenne Leads to 22% Staff Layoff
Wave Life Sciences is cutting about 22 percent of its staff as part of a corporate shakeup that follows the company’s decision to stop work on its Duchenne muscular dystrophy programs. Singapore-based Wave (NASDAQ: [[ticker:WVE]]), which has its US operations in Cambridge, MA, said in a Feb. 6 regulatory filing it expects to have notified … Continue reading “Wave Life Sciences’ Stumble in Duchenne Leads to 22% Staff Layoff”
Biohaven Drug Fails Anxiety Study, Data in OCD and More Still to Come
An experimental Biohaven Pharmaceutial therapy intended to treat anxiety has failed in a late-stage study, the first of four shots that the company is taking with the drug to try to address neurological disorders. The results released Monday for Biohaven (NASDAQ: [[ticker:BHVN]]) drug troriluzole were for generalized anxiety disorder, a persistent feeling of worry or … Continue reading “Biohaven Drug Fails Anxiety Study, Data in OCD and More Still to Come”
Eli Lilly, Roche Drugs Fail to Move Needle in Genetically Driven Alzheimer’s
Two experimental drugs from Eli Lilly and Roche have failed a clinical trial testing them as treatments for a form of Alzheimer’s disease caused by certain genetic mutations, the companies reported Monday. The study, sponsored by Washington University, tested the drugs in patients who have an early onset, inherited form of Alzheimer’s called autosomal dominant. … Continue reading “Eli Lilly, Roche Drugs Fail to Move Needle in Genetically Driven Alzheimer’s”
Complexa Appoints Elisabeth Leiderman Chief Business Officer
Elisabeth Leiderman has joined Complexa as chief business officer. She was most recently senior vice president and head of corporate development for Fortress Biotech (NASDAQ: [[ticker:FBIO]]). Berwyn, PA-based Complexa’s lead drug candidate, CXA-10, is in Phase 2 testing for focal segmental glomerulosclerosis and pulmonary arterial hypertension.
Bio Roundup: POTUS on Prices, a16z’s Fund, Aimmune’s Approval & More
The president’s State of the Union address was wide-ranging, as they tend to be, but those who tuned in heard mention of two hot health policy topics: price transparency and drug pricing reform. President Trump asserted that an executive order he signed last year directing various federal agencies to come up with new rules requiring … Continue reading “Bio Roundup: POTUS on Prices, a16z’s Fund, Aimmune’s Approval & More”
Myriad Genetics Exec Capone Resigns, Riggsbee Named Interim CEO
Longtime Myriad Genetics (NASDAQ: [[ticker:MYGN]]) president and CEO Mark Capone has resigned. The Salt Lake City-based molecular diagnostic company said Myriad and Capone—who has been with the company for 17 years—mutually agreed it was the right time for a leadership transition. Bryan Riggsbee, Myriad’s chief financial officer, was appointed interim president and CEO. He will … Continue reading “Myriad Genetics Exec Capone Resigns, Riggsbee Named Interim CEO”
Sonoma Bio Launches With $40M to Take Cell Therapy Beyond Cancer
Cell therapies have reached the market as a new treatment option for some cancers. But the scientists of Sonoma Biotherapeutics say this approach also holds promise for autoimmune disorders, and the biotech startup has unveiled $40 million in financing to develop its technology. The investors in Sonoma’s Series A round of funding include Lyell Immunopharma, … Continue reading “Sonoma Bio Launches With $40M to Take Cell Therapy Beyond Cancer”
Scripps Research’s Calibr to Test “Switchable” CAR-T in Clinical Trial
Scripps Research is charting new territory with its Calibr division, a drug discovery and drug development group within the research institute that is advancing its own experimental treatments. This week Calibr announced it had received the agency’s go-ahead to move a CAR-T cell therapy it has been evaluating for the treatment of certain blood cancers, … Continue reading “Scripps Research’s Calibr to Test “Switchable” CAR-T in Clinical Trial”
Early Bird Sale Ending for San Diego’s Xcelerating Life Sciences Conference
This is the last week to register at the lowest rate for March 18’s Xcelerating Life Sciences: Biomedical Breakthroughs in Precision Medicine & Genomics conference at the Takeda Research facility in San Diego. Hurry, our $99 early bird sale ends this Friday, Feb. 7 at midnight. Join Xconomy as we explore how the investment paradigm … Continue reading “Early Bird Sale Ending for San Diego’s Xcelerating Life Sciences Conference”
Beam Therapeutics IPO Raises $180M After Nearly Doubling Shares Offered
Gene editing biotech Beam Therapeutics raised $180 million in its initial public offering Wednesday after offering 48 percent more shares than it initially anticipated. Beam, which was slated to begin trading Thursday on the Nasdaq exchange under the stock symbol “BEAM,” sold 9.25 million shares, up from the 6.25 million it said it planned to … Continue reading “Beam Therapeutics IPO Raises $180M After Nearly Doubling Shares Offered”
Coda Bio Acquires Drug Candidates to Pair With Engineered Receptors
To have a therapeutic effect, drugs need to bind to proteins. But since it isn’t always possible to find an appropriate receptor, Coda Biotherapeutics is designing receptors, which it plans to deliver via engineered viruses, that respond only to a specific drug. On Wednesday the South San Francisco-based biotech announced it acquired a company called … Continue reading “Coda Bio Acquires Drug Candidates to Pair With Engineered Receptors”
Aimmune Gets $200M From Nestlé; Licenses Food Allergy Drug Candidate
Last week the FDA approved an Aimmune Therapeutics drug for children with peanut allergies, the first oral immunotherapy for a food allergy to get the agency’s nod. On Wednesday the Brisbane, CA-based biotech announced that one of its backers, Nestlé Health Science, had made a new $200 million equity investment that it will use to … Continue reading “Aimmune Gets $200M From Nestlé; Licenses Food Allergy Drug Candidate”
Merck Charts an R&D-Focused Course Starting With a $6.5B Spinoff
Merck is corralling products representing $6.5 billion in sales and spinning them off into a separate company, a strategic bet that focusing the remaining business on developing innovative new medicines will drive future growth. The new company will take Merck’s women’s health business, older medicines that have lost patent protection, and biosimilars—drugs that are close … Continue reading “Merck Charts an R&D-Focused Course Starting With a $6.5B Spinoff”
Titan Medical’s Cash Crunch Stalls Plans to Get Surgical Robot to FDA
Titan Medical didn’t meet its goal of submitting its robotic surgical system for FDA clearance by the end of 2019. Now the company says it needs another $85 million to get its medical device to the finish line or it might have to put itself up for sale. The robotic systems developer spelled out the … Continue reading “Titan Medical’s Cash Crunch Stalls Plans to Get Surgical Robot to FDA”
Verily, Santen See Ophthalmology Opportunity Via New Joint Venture
Verily, the life sciences spinout of Google parent Alphabet, has inked a deal with a Japanese ophthalmology company to develop digital tools and technologies to improve eye health. Santen Pharmaceutical, which is based in Osaka, has a global industrial and commercial ophthalmology business. Teaming up with Verily will enable it to apply the South San … Continue reading “Verily, Santen See Ophthalmology Opportunity Via New Joint Venture”
$750M Fund Looks to Software Sector to Drive Future of Biotech
Andreessen Horowitz (a16z), a Silicon Valley venture capital firm best known for backing high-flying software startups such as Facebook, Lyft, and Skype, is doubling down on its foray into biotech-related bets. A16z on Tuesday revealed it has raised $750 million for its third Bio Fund. The fund is bigger than its first two combined and … Continue reading “$750M Fund Looks to Software Sector to Drive Future of Biotech”
Bristol-Myers, BioMotiv Pact Leads to a New Fibrosis-Focused Startup
Bristol-Myers Squibb is still digesting the commercialized and clinical-stage assets that came with its $74 billion acquisition of Celgene, but the pharmaceutical giant has also been making moves to feed its pipeline with compounds at earlier points of development. An alliance that Bristol struck up with pharmaceutical accelerator BioMotiv last year now has its first … Continue reading “Bristol-Myers, BioMotiv Pact Leads to a New Fibrosis-Focused Startup”
Passage Bio Plans IPO as Three Gene Therapies Approach the Clinic
A year ago Passage Bio launched with $115.5 million and plans to advance a handful of gene therapies discovered at the University of Pennsylvania. Now the Philadelphia-based biotech is preparing to join the public markets and raise millions more to move its three lead programs into the clinic. Want more cell and gene therapy content? … Continue reading “Passage Bio Plans IPO as Three Gene Therapies Approach the Clinic”
Insmed Drug for Rare Pulmonary Disorder Meets Phase 2 Goals
Rare disease drug developer Insmed on Monday revealed data from a mid-stage trial of its daily pill for adults with non-cystic fibrosis bronchiectasis, a severe chronic pulmonary disorder with no FDA-approved therapies. Patients with chronic inflammatory lung diseases end up with an overabundance of white blood cells called neutrophils in their airways. The Insmed drug, … Continue reading “Insmed Drug for Rare Pulmonary Disorder Meets Phase 2 Goals”
United Therapeutics Drug Flunks Small Cell Lung Cancer Clinical Trial
An effort to expand use of a United Therapeutics oncology drug to the treatment of small cell lung cancer has fallen short. United Therapeutics (NASDAQ: [[ticker:UTHR]]) announced Monday that a Phase 2/3 study testing dinutuximab (Unituxin) did not meet the main goal of helping patients live longer. The Silver Spring, MD-based company says full data … Continue reading “United Therapeutics Drug Flunks Small Cell Lung Cancer Clinical Trial”
Discovery Labs Converts ex-GSK King of Prussia Site into R&D “Colony”
The MLP Ventures-funded Discovery Labs says it is “bending the rules” in its efforts to stimulate R&D at the former GlaxoSmithKline site through a limited governance financial model. In April 2018, GlaxoSmithKline (NYSE: [[ticker:GSK]]) sold its R&D campus in King of Prussia, PA, to private Philadelphia-based life science and real estate investment company MLP Ventures … Continue reading “Discovery Labs Converts ex-GSK King of Prussia Site into R&D “Colony””
Aimmune Awarded First FDA Approval for a Peanut Allergy Therapy
An Aimmune Therapeutics drug developed to treat peanut allergy won FDA approval late Friday—the first time the agency has approved an oral immunotherapy for a food allergy. The Aimmune (NASDAQ: [[ticker:AIMT]]) drug, Palforzia, was developed to desensitize patients to peanuts. The FDA decision covers patients between the ages of 4 and 17 who have a … Continue reading “Aimmune Awarded First FDA Approval for a Peanut Allergy Therapy”
Arcutis Bio Raises $159M in Upsized IPO to Test Skin Disease Drugs
Arcutis Biotherapeutics raised about $159 million from its IPO, offering 1.6 million more shares than anticipated and pricing at the high end of its planned range. The Westlake Village, CA-based biotech sold about 9.4 million of its shares at $17 apiece. Arcutis (NASDAQ: [[ticker:ARQT]]) shares began trading Friday. The stock price closed at $21.80, up … Continue reading “Arcutis Bio Raises $159M in Upsized IPO to Test Skin Disease Drugs”
Bio Roundup: Mammoth Moves, Black Diamond’s Pop, Ohana’s Debut & More
If this week is any indication, the steady march of life science companies to Wall Street will continue in 2020. Black Diamond Therapeutics is leading the way, having raised $201 million from its IPO. In its first day of trading, the cancer drug developer watched its shares soar more than 108 percent. Black Diamond’s stock … Continue reading “Bio Roundup: Mammoth Moves, Black Diamond’s Pop, Ohana’s Debut & More”
BIO Report: More Work Needed to Improve Diversity at Biotech Firms
Some companies that belong to the Biotechnology Industry Organization (BIO), a large industry trade group, convene diverse hiring committees, seek out representation among their suppliers and vendors, and are led by executives that talk regularly about the importance of an inclusive workforce. Others have no women or people of color as employees, gather no data … Continue reading “BIO Report: More Work Needed to Improve Diversity at Biotech Firms”
With $45M, Mammoth Bio Expects Big Things From Tiny CRISPR Cas14
Mammoth Biosciences set out to develop CRISPR-based diagnostics that could be faster and cheaper than what’s available today. Those diagnostics are still on the way, but Mammoth now has a new piece in its toolbox that could broaden the reach of these tests and expand the startup into therapeutic applications. To support development of these … Continue reading “With $45M, Mammoth Bio Expects Big Things From Tiny CRISPR Cas14”
Black Diamond’s Upsized IPO Raises $201M to Advance Its Cancer Drug R&D
A little more than a year ago, Black Diamond Therapeutics unveiled technology that analyzes genetic data to discover new cancer drugs. Today the company has $201 million from an IPO to advance the development of drugs stemming from that technology. Black Diamond priced its IPO late Wednesday, selling 10.5 million shares for $19 apiece. That … Continue reading “Black Diamond’s Upsized IPO Raises $201M to Advance Its Cancer Drug R&D”
Vizgen Launches With $14M to Market New Subcellular Imaging Technique
Scientists in a Harvard University lab developed an imaging technique that allows researchers to peer deep into tissue samples to learn more about the molecules and cellular organization within. That technology now has the backing of two venture capital firms that have funded a company to commercialize the technology. The Cambridge, MA-based startup, Vizgen, debuted … Continue reading “Vizgen Launches With $14M to Market New Subcellular Imaging Technique”
Annovis Bio Gets $12M in IPO to Target Trio of Neurotoxic Proteins
A Philadelphia-area biotech is developing therapies for neurodegenerative diseases it says have the potential to perform better than others by targeting multiple proteins involved in the brain’s breakdown. Now the company, Berwyn, PA-based Annovis Bio, has raised $12 million in an initial public offering to advance clinical development of its lead therapy in patients with … Continue reading “Annovis Bio Gets $12M in IPO to Target Trio of Neurotoxic Proteins”
Spring Bank Pharma Ends Hepatitis B Work After Death in Clinical Trial
Spring Bank Pharmaceuticals is stopping work on an experimental treatment for hepatitis B virus after serious side effects, including one patient death, were reported in a mid-stage study. The Spring Bank (NASDAQ: [[ticker:SBPH]]) drug, inarigivir soproxil, was the company’s lead therapeutic candidate. No details were released about the side effects observed in the clinical trial. … Continue reading “Spring Bank Pharma Ends Hepatitis B Work After Death in Clinical Trial”
Agenda and Speakers Announced for Xcelerating Life Sciences San Diego
The initial agenda and speaker lineup is now available for San Diego’s Xcelerating Life Sciences event on March 18 at Takeda Research in California. Join Xconomy as we bring together local innovators, entrepreneurs, and investors to explore bold new ideas in healthcare – and make the impactful connections. Agenda topics include Successful Research & Development … Continue reading “Agenda and Speakers Announced for Xcelerating Life Sciences San Diego”
Decibel Therapeutics Strikes a Balance, Adding Regenerative Med Focus
Decibel Therapeutics emerged four years ago aiming to build a pipeline of medicines for various forms of hearing loss. One of those drugs is in the clinic. Others were shelved. And some of the company’s resources are now focusing on regenerative therapies addressing the inner ear. The recent pipeline changes are accompanied by a corporate … Continue reading “Decibel Therapeutics Strikes a Balance, Adding Regenerative Med Focus”
Histogen, Timber Pharma Plan Reverse Mergers to Join Public Markets
Two privately held biotechs on Tuesday announced plans for reverse mergers, transactions that provide a faster route to go public than a conventional IPO and also give struggling public companies a chance to recoup some value for their shareholders. San Diego regenerative medicine company Histogen announced an agreement to gain a Nasdaq listing through a … Continue reading “Histogen, Timber Pharma Plan Reverse Mergers to Join Public Markets”
Third Time’s the Charm as Acceleron Drug Shows Early Promise in PAH
Sotatercept was one of the first compounds to emerge from the labs of Acceleron Pharma, but it became a forgotten piece of the company’s pipeline. Passed over as a candidate to treat a rare blood disorder and stalled in tests in chronic kidney disease, little was expected of the drug. The drug’s prospects have changed … Continue reading “Third Time’s the Charm as Acceleron Drug Shows Early Promise in PAH”
BioIntelliSense Debuts “Sticker” Sensor to Capture Patient Data Remotely
Subtle changes can presage a worsening of a chronic condition, but symptoms may not become apparent to a patient until it’s time to call an ambulance. BioIntelliSense, a Denver-based digital health startup, has developed a wearable sensor meant to monitor patients’ vital signs remotely and provide near real-time data that clinicians can use to identify … Continue reading “BioIntelliSense Debuts “Sticker” Sensor to Capture Patient Data Remotely”
Advanced Therapies Are Reshaping Biopharma R&D: KPMG Report
Biopharmaceutical companies focused on advanced therapies are changing industry R&D, manufacturing, and supply chain models according to KPMG. The audit, tax, and advisory services firm shared details of the trend in its Healthcare & Life Sciences Outlook report, explaining that for companies developing cell, gene, and nucleic acid-based therapies, innovation is a necessity. “As pharmaceutical … Continue reading “Advanced Therapies Are Reshaping Biopharma R&D: KPMG Report”
Flagship Adds Fertility-Focused Ohana Biosciences to Biotech Family
About 7 million couples in the US have difficulty getting or staying pregnant. A new biotech is using insights into the biology of male reproductive cells—the sperm that must meet its female equivalent, an egg cell, for fertilization to occur—to develop products meant to make assisted reproductive technologies such as in vitro fertilization (IVF) more … Continue reading “Flagship Adds Fertility-Focused Ohana Biosciences to Biotech Family”
Quench Bio Springs From Atlas With $50M for a New Take on Inflammation
Cells die all the time in a controlled manner that’s perfectly normal. But the way cells die matters. Sometimes cell death is violent, sparking inflammation believed to contribute to disease. Quench Bio aims to develop drugs that stop the uncontrolled forms of programmed cell death, potentially halting inflammatory disease. The Cambridge, MA-based startup has come … Continue reading “Quench Bio Springs From Atlas With $50M for a New Take on Inflammation”
Life Sciences IPOs Target Collective Raise of More Than $600M This Week
So far this year four privately held companies have made the transition to trading on the public markets. By month’s end, five more are anticipated to join the class of 2020 initial public offerings—and four of those are in life sciences, according to IPO research firm Renaissance Capital. Two are clinical-stage biotechs: Cambridge, MA-based Black … Continue reading “Life Sciences IPOs Target Collective Raise of More Than $600M This Week”
Allergan Offloads Two Drugs to Secure Approval of Merger With AbbVie
Allergan is selling off an experimental drug and a commercialized product in order to allay antitrust concerns from regulators reviewing the company’s $63 billion acquisition by AbbVie. The rights to brazikumab, which is currently in testing for Crohn’s disease and ulcerative colitis, will go to AstraZeneca (NYSE: [[ticker:AZN]]), where the antibody drug was initially developed. … Continue reading “Allergan Offloads Two Drugs to Secure Approval of Merger With AbbVie”