Author: Frank Vinluan

Xconomy Editor Frank Vinluan is a business journalist with experience covering technology and life sciences. Based in Raleigh, he was a staff writer at the Triangle Business Journal covering technology, biotechnology and energy before joining MedCityNews.com as North Carolina bureau chief. Prior to moving to North Carolina’s Research Triangle in 2007 he held business reporting positions at The Des Moines Register and The Seattle Times.

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”

Takeda’s Peng Lu Joins Pharvaris as Chief Medical Officer

Pharvaris has appointed Peng Lu to serve in the newly created position of chief medical officer. Lu joins the Leiden, Netherlands-based drug developer from Takeda Pharmaceutical (NYSE: [[ticker:TAK]]), where she was vice president and global program lead for rare diseases. Lu will be based in Pharvaris’s Boston office. The company’s lead drug candidate, PHA121, is … Continue reading “Takeda’s Peng Lu Joins Pharvaris as Chief Medical Officer”

Novartis’s Wotling to Join DBV as Chief Technical Operations Officer

DBV Technologies (NASDAQ: [[ticker:DBVT]]) has appointed Pascal Wotling to serve as its chief technical operations officer. He worked most recently at Novartis (NYSE: [[ticker:NVS]]), where he was head of external supply operations for the Asia-Pacific, Middle East, and Africa. He will start at Bagneux, France-based DBV on April 1. DBV is awaiting an FDA decision … Continue reading “Novartis’s Wotling to Join DBV as Chief Technical Operations Officer”

Aerami Therapeutics Appoints Timm Crowder Chief Operating Officer

Timm Crowder has joined Aerami Therapeutics as its chief operating officer, the same role he held most recently at Spyryx Biosciences. His experience also includes positions at GlaxoSmithKline (NYSE: [[ticker:GSK]]) and Oriel Therapeutics. Durham, NC-based Aerami is developing aerosol formulations of drugs that are administered via its “smart inhaler” technology. The company’s lead product candidate, … Continue reading “Aerami Therapeutics Appoints Timm Crowder Chief Operating Officer”

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”

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”

Portola Picks Adamas Pharma’s Patni for Chief Medical Officer Role

Rajiv Patni has joined Portola Pharmaceuticals (NASDAQ: [[ticker:PTLA]]) as executive vice president and chief medical officer. He comes to South San Francisco-based Portola from Adamas Pharmaceuticals (NASDAQ: [[ticker:ADMS]]), where he was chief medical officer. Patni’s experience also includes positions at Ocera Therapeutics, Actelion Pharmaceuticals, Roche, and Pfizer (NYSE: [[ticker:PFE]]). Portola has commercialized two FDA-approved therapies: … Continue reading “Portola Picks Adamas Pharma’s Patni for Chief Medical Officer Role”

BioMarin’s Spiegelman Steps Down, Mueller Steps Up as Acting CFO

Dan Spiegelman, chief financial officer of BioMarin Pharmaceutical (NASDAQ: [[ticker:BMRN]]) for the past eight years, has stepped down from his executive role. According to a securities filing, the job change took effect on Jan. 29. The San Rafael, CA-based rare disease drug developer says Spiegelman will continue as an employee and senior advisor until Sept. … Continue reading “BioMarin’s Spiegelman Steps Down, Mueller Steps Up as Acting CFO”

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”

CytomX Appoints Alison Hannah Senior VP and Chief Medical Officer

Alison Hannah has joined CytomX (NASDAQ: [[ticker:CTMX]]) as senior vice president and chief medical officer. Hannah was most recently a consultant to pharmaceutical and biotechnology companies. Her experience also includes positions at Sugen and Quintiles. South San Francisco-based CytomX is developing a type of cancer treatment it calls a “Probody drug.” The company’s pipeline includes … Continue reading “CytomX Appoints Alison Hannah Senior VP and Chief Medical Officer”

Boston Pharmaceuticals Picks NIBR’s Basson for Chief Medical Officer

Boston Pharmaceuticals has appointed Craig Basson to serve as its chief medical officer. He joins the Cambridge, MA, company from the Novartis Institutes for Biomedical Research (NIBR), where he was global head of translational medicine for the cardiovascular and metabolic therapeutic areas. Before joining Novartis, Basson was a professor of cardiology and internal medicine at … Continue reading “Boston Pharmaceuticals Picks NIBR’s Basson for Chief Medical Officer”

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”

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”

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”

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”

Anika Therapeutics Announces Passing of CEO Joseph Darling

Joseph Darling, president and CEO of Anika Therapeutics (NASDAQ: [[ticker:ANIK]]), has passed away, the company announced Wednesday. The company said that Darling, 62, died unexpectedly in upstate New York. No cause of death was disclosed. Anika develops and sells joint preservation and regenerative therapies for orthopedic conditions. Darling joined the Bedford, MA-based company as its … Continue reading “Anika Therapeutics Announces Passing of CEO Joseph Darling”

Decibel Therapeutics Exec Holtzman Retires, Reid Named Acting CEO

Decibel Therapeutics CEO Steven Holtzman is retiring, the Boston-based drug developer announced Wednesday. He will continue as a business advisor to the company. Decibel appointed Laurence Reid to serve as acting CEO. Reid is an entrepreneur-in-residence at Third Rock Ventures, one of Decibel’s investors. He is also the former CEO of Warp Drive Bio, which … Continue reading “Decibel Therapeutics Exec Holtzman Retires, Reid Named Acting CEO”

Takeda’s Blanchfield Joins Lantheus as Chief Commercial Officer

Lantheus Holdings has appointed Paul Blanchfield to serve as its chief commercial officer. Blanchfield was most recently head of US immunology at Japan’s Takeda Pharmaceutical (NYSE: [[ticker:TAK]]). Before, he held several different roles at Dublin, Ireland-based Shire, which Takeda acquired in January 2019. North Billerica, MA-based Lantheus Holdings is the parent company of LMI, a … Continue reading “Takeda’s Blanchfield Joins Lantheus as Chief Commercial Officer”

Biofourmis Adds Jaydev Thakkar, Milan Shah to C-Suite

Digital therapeutics company Biofourmis has appointed Jaydev Thakkar as its chief operating officer, and Milan Shah as its chief technology officer. Thakkar joins Boston-based Biofourmis after 14 years at Amgen (NASDAQ: [[ticker:AMGN]]), where he was most recently director of digital health and innovation. Shah joins from cybersecurity firm Uptycs, where he was co-founder and chief … Continue reading “Biofourmis Adds Jaydev Thakkar, Milan Shah to C-Suite”

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”

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”

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”

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”

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”

Beam Therapeutics Promotes Giuseppe Ciaramella to President

Beam Therapeutics has promoted Chief Scientific Officer Giuseppe “Pino” Ciaramella to president. He will continue to serve as the Cambridge, MA, biotech’s CSO, a role he has held for nearly two years. Before joining Beam, Ciaramella was the CSO of Moderna (NASDAQ: [[ticker:MRNA]]). His experience also includes positions at AstraZeneca (NYSE: [[ticker:AZN]]) and Boehringer Ingelheim. … Continue reading “Beam Therapeutics Promotes Giuseppe Ciaramella to President”

Acceleron Pharma Exec Quisel Is Leaving to Join a Biotech Startup

Acceleron Pharma (NASDAQ: [[ticker:XLRN]]) announced Thursday that John Quisel, the company’s executive vice president and chief business officer, is leaving to become CEO of a venture-backed biotechnology startup. The startup’s name was not disclosed. Quisel was involved in numerous deals struck by Cambridge, MA-based Acceleron, including a development and commercialization agreement with Celgene (now part … Continue reading “Acceleron Pharma Exec Quisel Is Leaving to Join a Biotech Startup”

Epizyme’s Soft Tissue Cancer Drug Granted Speedy FDA Approval

Epizyme won accelerated FDA approval Thursday for a drug developed to treat the rare cancer epithelioid sarcoma (ES). The regulatory decision for the Epizyme (NASDAQ: [[ticker:EPZM]]) drug, tazemetostat (Tazverik), covers patients 16 or older whose ES has advanced or spread and is not eligible for surgical treatment. The drug is now the first FDA-approved treatment … Continue reading “Epizyme’s Soft Tissue Cancer Drug Granted Speedy FDA Approval”

Poxel Picks Sigilon’s Moller for Chief Scientific Officer Post

David Moller has joined Poxel as its chief scientific officer, the same position he held most recently at Sigilon Therapeutics. Moller’s experience also includes research and development roles at Eli Lilly (NYSE: [[ticker:LLY]]) and Merck (NYSE: [[ticker:MRK]]). Lyon, France-based Poxel is developing treatments for metabolic diseases, including type 2 diabetes and nonalcoholic steatohepatitis. Moller will … Continue reading “Poxel Picks Sigilon’s Moller for Chief Scientific Officer Post”

Krystal Biotech Names Genzyme’s Chien Chief Commercial Officer

Gene therapy developer Krystal Biotech (NASDAQ: [[ticker:KRYS]]) has appointed Jennifer Chien to the newly created role of chief commercial officer. She comes to Pittsburgh-based Krystal from the Genzyme unit of Sanofi (NYSE: [[ticker:SNY]]), where she was vice president and head of genetic diseases. Krystal’s lead therapeutic candidate, KB103, is a topical gene therapy in mid-stage … Continue reading “Krystal Biotech Names Genzyme’s Chien Chief Commercial Officer”

FDA Flags Risk of Infection, Kidney Damage for Sarepta Duchenne Drugs

[Updated 7:25 p.m. See below.] Safety concerns stymied Sarepta Therapeutics’ attempt to win FDA approval last August for golodirsen (Vyondys 53), its second Duchenne muscular dystrophy drug. But an appeal of the decision led to a surprise reversal by the regulator last month, with little explanation why. Details are now surfacing about the safety risks … Continue reading “FDA Flags Risk of Infection, Kidney Damage for Sarepta Duchenne Drugs”

Emendo Eyes the Clinic for CRISPR Therapy That Makes Single-Gene Edits

CRISPR gene editing offers the potential to selectively edit the genetic mutations causing inherited diseases, but Emendo Biotherapeutics CEO David Baram contends it’s not precise enough. A large number of genetic diseases can’t be addressed by current CRISPR approaches and the technology still raises safety concerns. Emendo is developing a way to make CRISPR gene … Continue reading “Emendo Eyes the Clinic for CRISPR Therapy That Makes Single-Gene Edits”

Revolution Medicines Maps Out an IPO to Reach Cancer’s Frontiers

Cancer research has revealed proteins known to play a role in the disease, but with no known way of stopping what they do. In pharmaceutical parlance, they’re “undruggable.” Revolution Medicines is trying to drug the undruggable with small molecules that block the signaling pathways these proteins use to help cancer grow and thrive. With one … Continue reading “Revolution Medicines Maps Out an IPO to Reach Cancer’s Frontiers”

Bio Roundup: EQRx’s Ambitions, Nektar No Vote, New Frazier Fund & More

Perhaps the most talked-about news at the JP Morgan Healthcare Conference this week was a new startup that launched with $200 million and an ambitious claim that its first drug would be approved within five years, and 10 in total within as many years. Cambridge, MA-based EQRx contends it will be able achieve its goals … Continue reading “Bio Roundup: EQRx’s Ambitions, Nektar No Vote, New Frazier Fund & More”

BioCryst Pharma Promotes Charles Gayer to Chief Commercial Officer

BioCryst Pharmaceuticals (NASDAQ: [[ticker:BCRX]]) has promoted Charles Gayer to chief commercial officer. Gayer joined the Durham, NC-based drug developer in 2015 as vice president of global strategic marketing. His experience also includes positions at Talecris and GlaxoSmithKline (NYSE: [[ticker:GSK]]). BioCryst is preparing for the expected commercial launch of berotralstat, a drug that has been submitted … Continue reading “BioCryst Pharma Promotes Charles Gayer to Chief Commercial Officer”

Cancer Drug Developer BioNTech to Buy Neon Therapeutics in $67M Deal

Neon Therapeutics closed 2019 by curtailing its cancer vaccine programs and laying off 24 percent of its workforce, part of a corporate restructuring aimed at finding a new path for the company. That new path will now be as a division of cancer drug developer BioNTech. BioNTech announced Thursday that it has agreed to acquire … Continue reading “Cancer Drug Developer BioNTech to Buy Neon Therapeutics in $67M Deal”

Adaptimmune Appoints Elliot Norry Chief Medical Officer

Elliot Norry, acting chief medical officer of Adaptimmune (NASDAQ: [[ticker:ADAP]]) since last August, now holds the job outright. Norry initially joined the company in 2015 as head of clinical safety and pharmacovigilance. Adaptimmune, which splits its operations between Philadelphia and Oxfordshire, UK, is developing cancer immunotherapies based on its technology for engineering T cells.

Emendo Biotherapeutics Nabs $61M for “Next-Generation CRISPR” R&D

[Updated 1/22/20120, 7:17 a.m. See below.] Emendo Biotherapeutics, a company aiming to apply CRISPR gene editing to a wider range of genetic diseases, has raised $61 million in financing. The Series B round was led by AnGes, a Japan-based biopharmaceutical company. Want more cell and gene therapy content? Network and engage with industry leaders online … Continue reading “Emendo Biotherapeutics Nabs $61M for “Next-Generation CRISPR” R&D”

FDA Panel Votes Down Nektar Opioid Painkiller, Asks for More Data

[Updated 1/15/2020, 8:51 a.m. See below.] As the nation grapples with the ongoing opioid crisis, an FDA advisory panel on Tuesday unanimously voted against recommending approval of a Nektar Therapeutics painkiller that would add a new compound to the drug class—even though it was designed to reduce the risk of abuse. Some members of the … Continue reading “FDA Panel Votes Down Nektar Opioid Painkiller, Asks for More Data”

Schrödinger Sets Course for IPO to Support Growing Internal Pipeline

Scan the landscape of experimental medicines in development today and you’ll spot Schrödinger’s handiwork. The company’s software has helped discover compounds that are now advancing in the pipelines of several drug developers. Schrödinger isn’t shying away from that work. But as it continues building its own drug pipeline, it’s now laying out plans to go … Continue reading “Schrödinger Sets Course for IPO to Support Growing Internal Pipeline”

Incyte Commits $900M to MorphoSys for Rights to Lymphoma Drug

Two weeks after MorphoSys filed for FDA review of its experimental treatment for a form of lymphoma, the company has struck a deal with Incyte to further develop and commercialize the therapy in the US and around the world. According to financial terms announced Monday, Incyte (NASDAQ: [[ticker:INCY]]) is paying MorphoySys (NASDAQ: [[ticker:MOR]]) $750 million … Continue reading “Incyte Commits $900M to MorphoSys for Rights to Lymphoma Drug”

Generation Bio Pockets $110M for Next Wave of Gene Therapy, IPO Plans

JP Morgan’s annual healthcare conference convenes in San Francisco this week and Generation Bio CEO Geoff McDonough is betting gene therapy will be among the discussion topics. While such therapies now offer ways to address some rare diseases that previously had no treatment, they also have limitations. Generation Bio is among the new wave of … Continue reading “Generation Bio Pockets $110M for Next Wave of Gene Therapy, IPO Plans”

Eli Lilly Gets Skin in the Eczema Game With $1.1B Deal for Dermira

Eli Lilly has agreed to acquire dermatology drug developer Dermira and its late-stage atopic dermatitis drug for $1.1 billion. Lilly (NYSE: [[ticker:LLY]]) will pay $18.75 per share, a 2.2 percent premium over Dermira’s closing stock price on Thursday. But the deal price represents an 86 percent premium over the average price of Dermira shares over … Continue reading “Eli Lilly Gets Skin in the Eczema Game With $1.1B Deal for Dermira”

Biogen Teams Up With Startup CAMP4 to Scout for New Neuro Drugs

[Updated 2:42 p.m. See below.] The next neuroscience drug that joins Biogen’s pipeline might come from the research of startup CAMP4 Therapeutics. The two Cambridge, MA-based companies are starting an alliance that will use CAMP4’s technology to find genetic targets that could lead to new drugs. Biogen (NASDAQ: [[ticker:BIIB]]) is paying its new partner $15 … Continue reading “Biogen Teams Up With Startup CAMP4 to Scout for New Neuro Drugs”

Solid Bio Restructures to Get Halted Gene Therapy Study Back on Track

Solid Biosciences is slashing its workforce, including two top executives, in order to devote the company’s remaining resources to its experimental gene therapy for Duchenne muscular dystrophy. The corporate restructuring announced Thursday comes two months after the FDA placed a hold on the study after safety problems emerged that were linked to the gene therapy, … Continue reading “Solid Bio Restructures to Get Halted Gene Therapy Study Back on Track”