Marcia de Souza Lima has been appointed chief medical officer of eye drug developer Oculis. She most recently worked at Shire, where she was vice president and head of global medical affairs for ophthalmics. Her experience also includes positions at Regenxbio, Novartis (NYSE: [[ticker:NVS]]), Pfizer (NYSE: [[ticker:PFE]]), Bausch & Lomb, and Ancile Pharmaceuticals. Lausanne, Switzerland-based … Continue reading “Oculis Taps Shire Veteran de Souza Lima as Chief Medical Officer”
Gilead Boosts Cancer Drug Pipeline With $4.9B Deal for Forty Seven
Gilead Sciences, which finished 2019 with nearly $26 billion at its disposal, is putting some of that money to work with a $4.9 billion deal to acquire cancer immunotherapy developer Forty Seven. Under deal terms announced Monday, Foster City, CA-based Gilead (NASDAQ: [[ticker:GILD]]) will pay $95.50 for each share of Forty Seven (NASDAQ: [[ticker:FTSV]]). That’s … Continue reading “Gilead Boosts Cancer Drug Pipeline With $4.9B Deal for Forty Seven”
ORIC Pharma Plans IPO to Test Therapies for Drug-Resistant Cancers
With one investigational cancer drug in Phase 1 testing and a second one approaching the clinic, ORIC Pharmaceuticals is looking to tap the public markets for funds to finance that research. The company, which has set a preliminary target of about $86 million for its initial public offering, is looking to list on the Nasdaq … Continue reading “ORIC Pharma Plans IPO to Test Therapies for Drug-Resistant Cancers”
Xilio Unveils New Name, $100M to Bring Targeted Cancer Drugs to Clinic
Cancer immunotherapy’s use can be limited by its side effects throughout the body. Xilio Therapeutics is developing technology that selectively activates a therapy’s potent cancer-killing activity specifically at the tumor and it has raised $100.5 million to advance two programs to clinical testing. The financing was led by Takeda Ventures. Along with the new cash, … Continue reading “Xilio Unveils New Name, $100M to Bring Targeted Cancer Drugs to Clinic”
Biogen, Sangamo Ink Neuro Deal for New “Gene Regulation” Therapies
Biogen is opening up its checkbook again to get its hands on innovative approaches to some brain disorders that have proven especially recalcitrant to new types of treatment. The Cambridge, MA-based neuroscience drug developer is paying gene editing company Sangamo Therapeutics (NASDAQ: [[ticker:SGMO]]) $350 million up front in a collaboration on potential one-time treatments for … Continue reading “Biogen, Sangamo Ink Neuro Deal for New “Gene Regulation” Therapies”
Bio Roundup: COVID-19 Trials, Esperion’s Approvals, NASH News & More
Clinical trials have historically hewn to a rigid format. A trial is designed, conducted according to that design, and then results are analyzed. Making changes in the midst of the study was a no-no. In recent years, regulators have showed openness to clinical trial designs intended to make drug testing more efficient. We’ll get to … Continue reading “Bio Roundup: COVID-19 Trials, Esperion’s Approvals, NASH News & More”
Passage Bio’s IPO Raises $216M to Fund Gene Therapy Studies
Gene therapy developer Passage Bio priced its initial public offering at $18 per share, raising $216 million—72 percent more than it originally planned to raise. Earlier this month Passage filed to offer 7.4 million shares, but later increased that to 10 million, then 12 million, shares that sold at the high end of its $16 … Continue reading “Passage Bio’s IPO Raises $216M to Fund Gene Therapy Studies”
Biohaven’s Migraine Pill Is the Latest CGRP Drug to Win the FDA’s OK
[Updated 2/28/2020, 2:45 p.m. See below.] A Biohaven Pharmaceutical migraine drug has won FDA approval, clearing the way to the market for a new treatment option for the millions of people who suffer from the debilitating condition. The Biohaven (NYSE: [[ticker:BHVN]]) drug rimegepant (Nurtec) was developed for acute migraine in adults, treating a migraine attack … Continue reading “Biohaven’s Migraine Pill Is the Latest CGRP Drug to Win the FDA’s OK”
XenoTherapeutics Names Michael Yaremchuk as Its Chief Medical Officer
XenoTherapeutics on Wednesday named its first chief medical officer, Michael Yaremchuk. Boston-based XenoTherapeutics is working to advance what’s known as xenotransplantation, or the process of grafting or transplanting organs or tissues between members of different species. Its first product to enter the clinic, Xeno-Skin, is genetically engineered pig skin intended to temporarily close human burn … Continue reading “XenoTherapeutics Names Michael Yaremchuk as Its Chief Medical Officer”
Halozyme Therapeutics Appoints SutroVax’s Elaine Sun as New CFO
Halozyme Therapeutics (NASDAQ: [[ticker:HALO]]) this week appointed Elaine Sun as its senior vice president and chief financial officer. Sun, who starts March 2, succeeds Laurie Stelzer, who joined Halozyme as CFO in 2015. Stelzer recently resigned to pursue another employment opportunity, according to Halozyme. Sun was most recently as chief financial officer and chief strategy … Continue reading “Halozyme Therapeutics Appoints SutroVax’s Elaine Sun as New CFO”
Gilead, Moderna Candidates Ramp Up Coronavirus Drug, Vaccine Testing
An investigational antiviral drug Gilead Sciences has been developing to treat infections caused by the Ebola virus will be tested in about 1,000 adults diagnosed with COVID-19, the novel coronavirus that has infected tens of thousands of people and killed more than 2,500. On Wednesday, Foster City, CA-based Gilead (NASDAQ: [[ticker:GILD]]) announced the start of … Continue reading “Gilead, Moderna Candidates Ramp Up Coronavirus Drug, Vaccine Testing”
Nouscom’s Udier Named CEO, Delaite Appointed Chief Medical Officer
Nouscom interim CEO Marina Udier has been named the company’s permanent chief executive. Udier joined the Basel, Switzerland-based immunotherapy developer in 2016 as chief operating officer. She was appointed interim CEO last May following the retirement of founder and former CEO Alfredo Nicosia. In other moves, Nouscom appointed Patricia Delaite its chief medical officer. Delaite … Continue reading “Nouscom’s Udier Named CEO, Delaite Appointed Chief Medical Officer”
Adverum Promotes Angela Thedinga to Chief Technology Officer
Angela Thedinga has been appointed chief technology officer of Adverum Biotechnologies (NASDAQ: [[ticker:ADVM]]). She had joined the Redwood City, CA-based gene therapy developer last August as vice president of program management and strategy. Before Adverum, Thedinga was vice president of program management and chief of staff at AveXis, which is now a subsidiary of Novartis (NYSE: … Continue reading “Adverum Promotes Angela Thedinga to Chief Technology Officer”
Esperion’s Combo Pill for Lowering Cholesterol Levels Wins FDA Nod
An Esperion Therapeutics drug that pairs two cholesterol-lowering medicines in a single pill has been approved by the FDA, the second regulatory nod for the company in less than a week. The reglator’s decision covers the combination of Esperion’s bempedoic acid (Nexletol) and ezetimibe, an older generic drug for reducing levels of the “bad” form … Continue reading “Esperion’s Combo Pill for Lowering Cholesterol Levels Wins FDA Nod”
Takeda Bases PvP Biologics Buyout on Promising Early Celiac Drug Data
About three years ago fledgling San Diego-based startup PvP Biologics announced a $35 million deal with Takeda Pharmaceutical that gave the Japan pharma giant rights to acquire the company down the line. That day is here. Takeda (NYSE: [[ticker:TAK]]) acquired the company for an undisclosed amount up front, plus up to $330 million in payments … Continue reading “Takeda Bases PvP Biologics Buyout on Promising Early Celiac Drug Data”
With Foamix Merger Weeks Away, Menlo Itching Drug Fails a Phase 2 Test
A Menlo Therapeutics drug in testing for various itching conditions has failed a Phase 2 study, but executives say the results won’t translate to its lead itching target nor will they affect its pending merger with Foamix Pharmaceuticals. The Menlo (NASDAQ: [[ticker:MNLO]]) drug, serlopitant, is an experimental treatment for pruritus, itching that’s associated with a … Continue reading “With Foamix Merger Weeks Away, Menlo Itching Drug Fails a Phase 2 Test”
Skyhawk’s Terry Connolly Takes On New Role as Chief Operating Officer
Skyhawk Therapeutics has appointed Terry Connolly to serve as its chief operating officer. He had spent the past year as the Waltham, MA, company’s chief business officer. Before joining Skyhawk, Connolly held multiple roles at Celgene. Skyhawk is developing small molecule drugs that correct errors in RNA splicing. The company’s preclinical pipeline includes one program … Continue reading “Skyhawk’s Terry Connolly Takes On New Role as Chief Operating Officer”
Aurinia Taps Abeona’s Max Colao as Chief Commercial Officer
Aurinia Pharmaceuticals (NASDAQ: [[ticker:AUPH]]) has named Max Colao to the newly created position of chief commercial officer. He joins Victoria, BC-based Aurinia from Abeona Therapeutics (NASDAQ: [[ticker:ABEO]]), where he was executive vice president, chief commercial officer, and head of business development. Colao’s experience also includes positions at Alexion Pharmaceuticals (NASDAQ: [[ticker:ALXN]]) and Amgen (NASDAQ: [[ticker:AMGN]]). … Continue reading “Aurinia Taps Abeona’s Max Colao as Chief Commercial Officer”
Bicycle Therapeutics Lands $30M From Genentech in New Cancer R&D Pact
Genentech is the latest company to enter a drug discovery partnership with Bicycle Therapeutics, adding a new alliance in cancer research for the clinical-stage biotech. Under an agreement announced Tuesday, Roche subsidiary Genentech is paying Bicycle (NASDAQ: [[ticker:BCYC]]) $30 million up front. As programs progress, Bicycle could earn up to $1.7 billion in total milestone … Continue reading “Bicycle Therapeutics Lands $30M From Genentech in New Cancer R&D Pact”
UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System
At the end of the Brexit transition period, the UK will be charting its own course through the often choppy seas of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced … Continue reading “UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System”
Esperion’s FDA-Approved Cholesterol Drug Priced Even Lower Than Expected
As Esperion Therapeutics steered its cholesterol-lowering drug through clinical testing and regulatory review, CEO Tim Mayleben did something unusual for a pharmaceutical executive: he spoke openly about price. Specifically, he talked about how inexpensive the drug would be. As early as two years ago, Mayleben said an FDA-approved Esperion (NASDAQ: [[ticker:ESPR]]) drug would cost patients … Continue reading “Esperion’s FDA-Approved Cholesterol Drug Priced Even Lower Than Expected”
NGM Bio’s NASH Drug Shows Promise, Shares Rise on Early Phase 2 Data
In what looks to be a transformative year for potential treatments of nonalcoholic steatohepatitis, the liver disease better known as NASH, another biotech has revealed that its experimental drug appears to improve the condition compared to a placebo. NGM Biopharmaceuticals (NASDAQ: [[ticker:NGM]]) revealed preliminary data on Monday showing that 22 percent of patients who received … Continue reading “NGM Bio’s NASH Drug Shows Promise, Shares Rise on Early Phase 2 Data”
Invetx Fetches $15M to Develop Biologic Drugs for Man’s Best Friend
Veterinarians have a saying that a cat is not a small dog, says Invetx CEO Juergen Horn. Obviously, a dog of any size isn’t the same as a human. But Horn, a veterinarian, says there are enough similarities between the species to take the science behind biological drugs for people and apply it to animals. … Continue reading “Invetx Fetches $15M to Develop Biologic Drugs for Man’s Best Friend”
Lundbeck’s Alder Bio Bet Pays Off With FDA Approval of Migraine Drug
A migraine drug that Lundbeck added to its pipeline via its nearly $2 billion acquisition of Alder BioPharmaceuticals won FDA approval on Friday. The drug, eptinezumab (Vyepti), is part of a new class of antibody therapies developed to prevent migraine attacks before they start. These drugs block calcitonin gene-related peptide (CGRP), a protein associated with … Continue reading “Lundbeck’s Alder Bio Bet Pays Off With FDA Approval of Migraine Drug”
Bio Roundup: Agile Approval, Coronavirus Collabs, Spruce’s $88M & More
The price of insulin, a life-saving treatment discovered a century ago, has been a flashpoint amid the broader drug pricing debate. The FDA is trying to tame high insulin prices by encouraging price competition. The FDA has historically regarded insulin as a drug. But insulin isn’t a chemical drug, it’s made from biological material. Under … Continue reading “Bio Roundup: Agile Approval, Coronavirus Collabs, Spruce’s $88M & More”
SeaGen Adds Five Prime Therapeutics Antibodies in Licensing Deal
Since a major restructuring at Five Prime Therapeutics in October that kicked off a wind-down of most of its research and preclinical efforts, the company has been looking to add to its partnerships portfolio. On Wednesday, South San Francisco-based Five Prime (NASDAQ: [[ticker:FPRX]]) said it inked one such new deal. The agreement, a license deal … Continue reading “SeaGen Adds Five Prime Therapeutics Antibodies in Licensing Deal”
Turning Point Taps eFFECTOR’s Reich as Its Chief Scientific Officer
Precision oncology company Turning Point Therapeutics (NASDAQ: [[ticker:TPTX]]) on Thursday said it has appointed Siegfried Reich as executive vice president and chief scientific officer. Reich, whose new role starts March 2, was most recently senior vice president of research at another San Diego-based cancer drug developer, eFFECTOR Therapeutics, which he co-founded. Reich’s experience includes time … Continue reading “Turning Point Taps eFFECTOR’s Reich as Its Chief Scientific Officer”
Spruce Bio Raises $88M for Clinical Tests of Rare Endocrine Disease Drug
Spruce Biosciences has raised $88 million to advance clinical testing of a drug for a rare inherited endocrine disorder that can lead to a potentially life-threatening hormonal imbalance. San Francisco-based Spruce aims to treat a form of congenital adrenal hyperplasia (CAH), an inherited condition that leads to a deficiency in enzymes needed to produce certain … Continue reading “Spruce Bio Raises $88M for Clinical Tests of Rare Endocrine Disease Drug”
EnClear Therapies Nets $10M to Test Neuro Disease ‘Dialysis’ Device
Many companies are working to develop new drugs that target harmful proteins associated with neurodegenerative diseases. EnClear Therapies has raised a $10 million Series A round of financing from a syndicate of investors to advance a device that it says could help treat neurodegenerative diseases by filtering out such proteins from cerebral spinal fluid (CSF), … Continue reading “EnClear Therapies Nets $10M to Test Neuro Disease ‘Dialysis’ Device”
Teva Drug Fails to Beat Placebo in Pediatric Tourette Patient Trials
A Teva Pharmaceutical drug in testing as a treatment for tics in pediatric patients with moderate-to-severe Tourette syndrome has failed two late-stage trials. Israel-based Teva (NYSE: [[ticker:TEVA]]) said Wednesday that the drug, deutetrabenazine, didn’t beat a placebo in reducing motor and phonic tics—the main goals of the Phase 2/3 and Phase 3 trials. Those signs … Continue reading “Teva Drug Fails to Beat Placebo in Pediatric Tourette Patient Trials”
Endo Names Blaise Coleman Successor to Retiring CEO Paul Campanelli
Endo International’s search for retiring CEO Paul Campanelli’s successor is ending close to home. Dublin, Ireland-based Endo (NASDAQ: [[ticker:ENDP]]) announced Wednesday that Chief Financial Officer Blaise Coleman will become president and CEO starting March 6. He will also take a seat on Endo’s board of directors. Before joining Endo in 2015, Coleman held leadership roles … Continue reading “Endo Names Blaise Coleman Successor to Retiring CEO Paul Campanelli”
Pfizer Veteran Clavelli Appointed Optinose Chief Commercial Officer
Victor Clavelli has been appointed chief commercial officer of Optinose (NASDAQ: [[ticker:OPTN]]). He joins the Yardley, PA-based company from Pfizer (NYSE: [[ticker:PFE]]), where he was most recently the company’s North American president for inflammation and immunology. Optinose develops and sells products addressing conditions of the ear, nose, and throat.
Xcelerating Life Sciences Boston Will Explore Biopharma’s Future in Digital Health
Join Xconomy on April 29 at Takeda Pharmaceuticals’ Boston location for the next in our Xcelerating Life Sciences event series: Biopharma’s Future in Digital Health. The half-day conference will bring together innovators, executives, rising pioneers, entrepreneurs, investors, and scientists to examine what’s fueling Boston’s biotech investment and partnership opportunities. As the nation’s largest biopharma cluster, … Continue reading “Xcelerating Life Sciences Boston Will Explore Biopharma’s Future in Digital Health”
ResTORbio Pins “Strategic Alternatives” Pitch to Parkinson’s Promise
Three months after resTORbio’s lead drug failed a pivotal test treating lung infections in the elderly, the company is now looking for someone to buy the firm or strike a deal for its technology. In a corporate update issued Wednesday, resTORbio (NASDAQ: [[ticker:TORC]]) says it has started a process to evaluate “partnerships, acquisitions, mergers, and … Continue reading “ResTORbio Pins “Strategic Alternatives” Pitch to Parkinson’s Promise”
Five Prime, Bristol Pancreatic Cancer Drug Combo Fails Phase 2 Test
A year ago Five Prime Therapeutics cut a fifth of its workforce to save money as its worked to advance its clinical-stage drugs for solid tumor cancers. On Tuesday the company (NASDAQ: [[ticker:FPRX]]) said one of those drugs, cabiralizumab, a Five Prime antibody that Bristol-Myers Squibb (NYSE: [[ticker:BMY]]) was testing in combination with its cancer immunotherapy … Continue reading “Five Prime, Bristol Pancreatic Cancer Drug Combo Fails Phase 2 Test”
Shattuck Labs Promotes Schreiber to CEO, Succeeding Hornblower
Taylor Schreiber, chief scientific officer and co-founder of Shattuck Labs, has been promoted to CEO. He succeeds Josiah Hornblower, who will continue to advise Shattuck as executive chairman of the company’s board of directors. Founded in 2016, Austin, TX-based Shattuck is developing “fusion protein” therapies to treat cancer. The company’s most advanced program, SL-279252, is … Continue reading “Shattuck Labs Promotes Schreiber to CEO, Succeeding Hornblower”
Adaptimmune Taps Abcam’s Gavin Wood for Chief Financial Officer Role
Gavin Wood has joined Adaptimmune Therapeutics (NASDAQ: [[ticker:ADAP]]) as chief financial officer, the same role he held most recently at Abcam. His experience also includes senior positions at Affymetrix. Adaptimmune, which splits its operations between Philadelphia and Oxfordshire, UK, is developing cancer immunotherapies based on its proprietary SPEAR T cell platform.
Xcelerating Life Sciences Boston (interactive online event)
Stay at the forefront of Boston’s technology and digital health advancements as biopharma, investment, and government come together to drive life sciences As the nation’s largest biopharma cluster, Boston has a proven track record of life science leadership, including emerging therapeutics. Digital technologies will play a critical role in the expansion of this industry poised … Continue reading “Xcelerating Life Sciences Boston (interactive online event)”
Imara Reveals IPO Plan as Sickle Cell Drug Advances in the Clinic
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”
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”
Voyager Therapeutics Chief Operating Officer Matthew Ottmer Resigns
Gene therapy developer Voyager Therapeutics (NASDAQ: [[ticker:VYGR]]) has lost its chief operating officer. Matthew Ottmer, who held the role since September 2017, resigned effective Feb. 12, according to a Friday securities filing. No reason was given. Though Ottmer has stepped down from his executive role, he will remain an at-will employee of Cambridge, MA-based Voyager … Continue reading “Voyager Therapeutics Chief Operating Officer Matthew Ottmer Resigns”
Immmunomedics Taps MedCo Veteran Loretta Itri as Chief Medical Officer
Immunomedics (NASDAQ: [[ticker:IMMU]]) has appointed Loretta Itri to serve as chief medical officer. Itri was most recently executive vice president of global health sciences & regulatory affairs at The Medicines Company. Her experience also includes roles at Genta, Johnson & Johnson (NYSE: [[ticker:JNJ]]), Ortho Biotech, and Roche. Morris Plains, NJ-based Immunomedics is awaiting an FDA … Continue reading “Immmunomedics Taps MedCo Veteran Loretta Itri as Chief Medical Officer”
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”
Xcelerating Life Sciences San Francisco (interactive online event)
Stay at the forefront of San Francisco’s AI, data, and R&D boom that is fueling today’s biotech investment and partnership opportunities It’s no surprise that San Francisco has ties with the digital community – but how does the health and life science field benefit? There are also challenges that come with the boom in the … Continue reading “Xcelerating Life Sciences San Francisco (interactive online event)”
Anika Therapeutics Appoints Cheryl Blanchard Interim CEO
Anika Therapeutics (NASDAQ: [[ticker:ANIK]]) board member Cheryl Blanchard has been named interim CEO of the company. Her appointment comes two weeks after the death of CEO Joseph Darling. With Blanchard stepping into her new role, the interim “Office of the President” that was created to take on Darling’s duties has been dissolved. Blanchard has been … Continue reading “Anika Therapeutics Appoints Cheryl Blanchard Interim CEO”
Palleon Pharma Promotes Li Peng to Chief Scientific Officer
Li Peng is taking on a new role at Palleon Pharmaceuticals as the company’s first chief scientific officer. Peng was previously Palleon’s vice president of research and early product development. Before joining the company, Peng held various roles at AstraZeneca (NYSE: [[ticker:AZN]]). Palleon is developing drugs that target the Siglec-Sialoglycan axis, a mechanism of immune … Continue reading “Palleon Pharma Promotes Li Peng to Chief Scientific Officer”
Pioneering Women in Personalized Medicine
Join the San Francisco Bay Area chapter of Women In Bio on March 24, 2020 for a special evening event at Magnolia Brewing in the Dogpatch in San Francisco to celebrate Women’s History Month! This event will highlight pioneering women that are leading the way in the advancement of precision medicine. We will kick off … Continue reading “Pioneering Women in Personalized Medicine”
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”