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”
Category: Europe
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”
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”
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”
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”
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”
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”
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.”
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”
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”
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”
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”
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”
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”
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”
Bio Roundup: Coronavirus Concerns, Sarepta’s CRL, Eye Drug OK’d & More
Company news slowed somewhat this week, perhaps as some took the federal Martin Luther King Jr. Day holiday away from the office and others recovered from back-to-back meetings and late nights at the JP Morgan Healthcare Conference. However, a new coronavirus believed to stem from Wuhan, China, captured the attention of the world healthcare community. … Continue reading “Bio Roundup: Coronavirus Concerns, Sarepta’s CRL, Eye Drug OK’d & More”
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”
After AstraZeneca, Osbourn Reflects on Roles at CAT & MedImmune
MedImmune, AstraZeneca’s biologics division, is no more. The pharmaceutical giant announced last year that the name would be retired as part of a research and development restructuring. Before MedImmune became an AstraZeneca (NYSE: [[ticker:AZN]]) business unit, it was a standalone biologics company. In 2007, AstraZeneca paid $15.2 billion to acquire the biotech, which it integrated … Continue reading “After AstraZeneca, Osbourn Reflects on Roles at CAT & MedImmune”
Horizon Gets Early FDA OK for First Thyroid Eye Disease Treatment
The first treatment for a rare disease that causes eye bulging and double vision received an FDA nod on Tuesday, weeks ahead of the agency’s March 8 deadline to review the drug. Dublin, Ireland-based Horizon Therapeutics (NASDAQ: [[ticker:HZNP]]) tested the medicine, teprotumumab-trbw (Tepezza), in thyroid eye disease, which occurs when the muscles and fatty tissues … Continue reading “Horizon Gets Early FDA OK for First Thyroid Eye Disease Treatment”
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”
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”
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”
Daré Bioscience Inks Deal With Bayer for Non-Hormonal Contraceptive
Daré Bioscience launched in 2015 with the aim of assembling a portfolio of novel women’s health products intended to pique interest from major pharmaceutical companies. Now the San Diego-based company has inked its first deal with Big Pharma, signing an agreement with German biopharma Bayer for its lead asset, a monthly non-hormonal form of birth … Continue reading “Daré Bioscience Inks Deal With Bayer for Non-Hormonal Contraceptive”
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”
Neurocrine, in Second Epilepsy Deal, Pairs With Swiss Biotech Idorsia
Neurocrine Biosciences is doubling down on epilepsy, striking its second agreement in as many months with a new deal that grants it the option to license an investigational treatment for a rare form of the disease. The San Diego-based drug developer (NASDAQ: [[ticker:NBIX]]) last month struck a deal with Xenon Pharmaceuticals (NASDAQ: [[ticker:XENE]]) that added … Continue reading “Neurocrine, in Second Epilepsy Deal, Pairs With Swiss Biotech Idorsia”
Biotech Roundup: Drug Pricing Promises, Bone Disease Data, IPO Plans & More
A letter signed by 215 people involved in the biopharma industry, including CEOs and investors, published Wednesday promised to put the “interests of patients first.” Six CEOs, including five who run public companies, co-authored the letter. Signatories agreed to what they dubbed a New Commitment to Patients, a list of “core principals and actions” promising … Continue reading “Biotech Roundup: Drug Pricing Promises, Bone Disease Data, IPO Plans & More”
Saniona Taps Former Sobi North America President Rami Levin as New CEO
Saniona, a Danish clinical-stage biotech company focused on rare diseases, named Rami Levin its new CEO. Levin was most recently president of the North America unit of Sobi, a rare disease biopharma headquartered in Sweden. He succeeds Jørgen Drejer, a Saniona founder, who will continue as chief scientific officer. Levin, who will be based in … Continue reading “Saniona Taps Former Sobi North America President Rami Levin as New CEO”
UK Startups Double in Number Backed By Larger Scale Investments: Report
Investors pumped £2.8 billion ($3.67 billion) into UK-based startups between 2014-2018, marking a four-fold increase from the previous five-year time period, according to a report published by the Nottingham-based incubator, BioCity. Among the biggest changes in this space over the past five years has been an increase in the scale of investments made into early-stage … Continue reading “UK Startups Double in Number Backed By Larger Scale Investments: Report”
Novo Holdings Repositions Antibiotics Funding Amid “Deteriorated” Market
Novo Holdings is repositioning the strategic focus of its REPAIR Fund in order to provide later-stage support to its portfolio companies, as the struggling antibiotics industry faces a dearth of investment. The Danish investor launched its REPAIR Impact Fund in 2018. An acronym for “Replenishing and Enabling the Pipeline for Anti-Infective Resistance,” the fund has … Continue reading “Novo Holdings Repositions Antibiotics Funding Amid “Deteriorated” Market”
Celgene-Seeded PharmAkea Sells Last Fibrotic Drug Candidate to Galecto
When a group of scientists from Amira Pharmaceuticals wanted to start a new biotech after the company’s 2011 acquisition by Bristol-Myers Squibb, Celgene provided seed funding. Eventually Celgene kicked in $35 million more for a research collaboration, an equity stake, and an exclusive option to acquire the startup, PharmAkea Therapeutics. But the partnership fizzled, and … Continue reading “Celgene-Seeded PharmAkea Sells Last Fibrotic Drug Candidate to Galecto”
Black Diamond Lines Up IPO as Lead Cancer Drug Nears Clinic
Cancer research is leading some companies to molecular targets that have eluded new medicines. Phase 1-ready biotech Black Diamond Therapeutics hopes its approach to such cancer targets leads it to the public markets. Black Diamond filed paperwork with securities regulators late Friday for an IPO. The Cambridge, MA-based firm set a $100 million goal for … Continue reading “Black Diamond Lines Up IPO as Lead Cancer Drug Nears Clinic”
Bio Roundup: FDA Approvals, Intrexon’s Shift, Melinta Bankruptcy & More
In the week leading up to Christmas, six drugs won FDA approvals. The decisions covered insomnia, migraine, and several different forms of cancer. The FDA’s final tally for the year totaled 48 new drug approvals. If you’re keeping score, that compares with 59 approvals in 2018 and 46 in 2017. Most of the nods went to … Continue reading “Bio Roundup: FDA Approvals, Intrexon’s Shift, Melinta Bankruptcy & More”
Rexgenero CEO Talks Importance of “Dialogue” in Cell Therapy Conversations
Cell and gene therapies are becoming more mainstream, but an essential aspect of the drug development process is talking with clinicians about how it would fit into their practice, according to Joe Dupere, CEO of UK-based regenerative medicine company Rexgenero. Rexgenero is advancing an experimental cell therapy for critical limb ischemia, a chronic condition that … Continue reading “Rexgenero CEO Talks Importance of “Dialogue” in Cell Therapy Conversations”
Allergan Wins FDA Nod for First Migraine Pill in New Class of Medicines
The FDA on Monday approved a pill from Allergan to treat migraine in adults. The treatment, ubrogepant (Ubrelvy), is part of a new class of migraine medicines designed to block calcitonin gene-related peptide (CGRP), a protein thought to play a role in pain transmission. Ubrogepant is the first CGRP drug in tablet form to get … Continue reading “Allergan Wins FDA Nod for First Migraine Pill in New Class of Medicines”
Roche Puts Up Historic $1.15B for Sarepta Duchenne Gene Therapy Deal
Swiss biopharma Roche is betting more than $1 billion that Sarepta Therapeutics, which recently won FDA approval for its second RNA medicine for Duchenne muscular dystrophy, will get its lead gene therapy treatment across the finish line too. The deal, one of the biggest ever US biopharma licensing agreements, gives Roche the right outside of … Continue reading “Roche Puts Up Historic $1.15B for Sarepta Duchenne Gene Therapy Deal”
Bio Roundup: Amarin’s Approval, FTC v. Illumina, a $120M Deal & More
As national politics dominates the news in the final days of the decade, we at Xconomy are wrapping up the year with some big moves by the FDA, including an approval of the first drug OK’d reduce heart risk in patients with high triglycerides who are already taking statins. Holidays don’t provide immunity to bad … Continue reading “Bio Roundup: Amarin’s Approval, FTC v. Illumina, a $120M Deal & More”
FTC Challenges PacBio Acquisition, Says Illumina is a “Monopolist”
About one year ago Illumina agreed to splash out $1.2 billion on Pacific Biosciences, a rival maker of DNA sequencing technology. Now the Federal Trade Commission is looking to block the deal, and says it was meant to steamroll a competitor and maintain Illumina’s “monopolist” position atop the industry. The San Diego-based genomics giant (NASDAQ: … Continue reading “FTC Challenges PacBio Acquisition, Says Illumina is a “Monopolist””
ALS Fund Talks Investments and Strategy as it Kicks Off $100M Campaign
The ALS Investment Fund has teamed with the ALS Association and is looking to establish new partnerships as part of its efforts to raise $100 million and collate a diversified set of portfolio companies. Craig Boyce, managing partner of the ALS Investment Fund, tells Xconomy it would have been crazy to start the fund 25 … Continue reading “ALS Fund Talks Investments and Strategy as it Kicks Off $100M Campaign”
Cell Reprogramming Startup Bit Bio Inks Pact With Charles River
Charles River Laboratories International is making moves in the cell therapy space after signing on the cell reprogramming startup Bit Bio and announcing plans to acquire a biomaterials company for $380 million. The Wilmington, MA-based contract research organization (CRO) last week announced that it has entered into an exclusive discovery and safety services partnership with … Continue reading “Cell Reprogramming Startup Bit Bio Inks Pact With Charles River”
Bio Roundup: Sarepta’s Approval, Merck M&A, Drug Price Bill & More
If you’re keeping track, FDA drug approvals have been on a tear in the past month with several decisions coming well ahead of their targeted dates. And then there’s Sarepta Therapeutics. Late Thursday, the FDA announced approval of the Cambridge, MA, biotech’s drug for Duchenne muscular dystrophy in patients who have a specific mutation. The … Continue reading “Bio Roundup: Sarepta’s Approval, Merck M&A, Drug Price Bill & More”
Amgen’s Osteoporosis Drug Wins European Nod, With a Heart Warning
An osteoporosis drug developed by Amgen now has marketing approval in Europe, but it carries a warning that the medicine can raise the risk of cardiovascular problems. Romosozumab (Evenity) treats postmenopausal woman who have osteoporosis, a disease that weakens bones, making them susceptible to fracture. The antibody drug, given as a monthly injection, was developed … Continue reading “Amgen’s Osteoporosis Drug Wins European Nod, With a Heart Warning”
Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink
Iterum Therapeutics’ bid to bring patients a new antibiotic that’s safer than currently available drugs has fallen short of the main efficacy goal of a late-stage clinical trial. But the company is pinning its hopes on another Phase 3 study that will report data early next year. Iterum (NASDAQ: [[ticker:ITRM]]) reported preliminary Phase 3 data … Continue reading “Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink”