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”
Category: National
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”
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”
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”
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”
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”
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”
CEOs of Women’s Health Companies Fight to Open Investment Floodgates
Talking about sex with potential investors? For EvoFem Biosciences CEO Saundra Pelletier, it’s the first item on the docket. Her company recently submitted Amphora, a non-hormonal contraceptive gel, to the FDA for review. EvoFem (NASDAQ: [[ticker:EVFM]])—and the rest of the women’s health sector—will know by midyear whether the product will be approved, making the San … Continue reading “CEOs of Women’s Health Companies Fight to Open Investment Floodgates”
After Ending Cancer Drug Program, Halozyme Predicts Profits in 2020
Halozyme suffered a setback in November when its investigational pancreatic drug failed a Phase 3 clinical trial, but its CEO says the biotech’s drug delivery technology will make the company profitable as early as the second quarter of this year. The San Diego-based company’s technology, called Enhanze, allows some drugs traditionally given intravenously over hours … Continue reading “After Ending Cancer Drug Program, Halozyme Predicts Profits in 2020”
Of Science and Sea Urchins: Researchers Plumb Oceans for Biological Insights
The ocean is home to more biodiversity than anywhere else on the planet—making it a largely untapped source of opportunity for researchers studying marine organisms as a source of novel drug leads. “The unique adaptations of marine organisms have made them valuable models for biomedical research, enhancing our understanding of fundamental biological processes, such as … Continue reading “Of Science and Sea Urchins: Researchers Plumb Oceans for Biological Insights”
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”
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.
Event Announcement: Xcelerating Life Sciences San Diego
We’re excited to announce the first in Xconomy’s new Xcelerating Life Sciences event series convening local communities of innovators, executives, rising pioneers, entrepreneurs, investors, and scientists: Xcelerating Life Sciences San Diego will help you stay at the forefront of San Diego’s genomic trends and technologies that are fueling today’s biotech investment and partnership opportunities. Early … Continue reading “Event Announcement: Xcelerating Life Sciences San Diego”
Mayo Clinic Joins $60M Financing for Biomedical Software Firm nference
Startup nference has closed a $60 million Series B financing round to expand the use of its augmented intelligence platform in clinical research and drug development. Mayo Clinic and NTT Venture Capital joined previous investors Matrix Partners and Matrix Capital Management, which participated in the Cambridge, MA-based company’s Series A round in 2018. The relationship … Continue reading “Mayo Clinic Joins $60M Financing for Biomedical Software Firm nference”
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”
Phage Therapy Firm APT Lands DoD Contract for Antibiotic Alternative
The Department of Defense has awarded Adaptive Phage Therapeutics a $10.2 million contract to help advance its experimental therapy for the treatment of multidrug-resistant infections. Gaithersburg, MD-based Adaptive Phage Therapeutics (APT) says it will pursue a two-year multi-site clinical trial as it looks to get the OK from the FDA, which considers phage to be … Continue reading “Phage Therapy Firm APT Lands DoD Contract for Antibiotic Alternative”
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”
Pfizer Taps Insilico Medicine to Use AI for Drug Target Discovery
Insilico Medicine on Tuesday announced that it has entered a research collaboration with Pfizer, which Insilico CEO Alex Zhavoronkov says has “one of the most advanced AI teams internally both in target identification and chemistry.” Under the agreement, Pfizer (NYSE: [[ticker:PFE]]) will use Insilico’s machine learning technology and proprietary Pandomics Discovery Platform. Pfizer, not new … Continue reading “Pfizer Taps Insilico Medicine to Use AI for Drug Target Discovery”
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”
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”
NeoGenomics Nabs Human Longevity’s Oncology Division for $37M
The genetic testing company NeoGenomics has acquired Human Longevity’s oncology division, which provides next-generation sequencing services. The division of San Diego-based Human Longevity generated approximately $10 million in revenue in 2019—an amount NeoGenomics (NASDAQ: [[ticker:NEO]]) thinks it can grow by nearly 50 percent, says Charlie Eidson, investor relations and corporate development analyst, NeoGenomics. Additionally, the … Continue reading “NeoGenomics Nabs Human Longevity’s Oncology Division for $37M”
Biogen Adds Another Neuro Drug to Pipeline in Deal With Pfizer
Continuing to make headlines in the neurodegenerative disease space, Biogen on Monday announced a deal to acquire a clinical-stage Pfizer asset that has potential applications in Alzheimer’s and Parkinson’s disease, for $75 million. Cambridge, MA-based Biogen (NASDAQ: [[ticker:BIIB]]) could end up paying Pfizer (NYSE: [[ticker:PFE]]) up to $635 million in potential milestone payments and royalties, … Continue reading “Biogen Adds Another Neuro Drug to Pipeline in Deal With Pfizer”
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”
Roche Pays $40M to Use Amunix Pharma’s Half-Life Extension Tech
Roche will pay Amunix Pharmaceuticals $40 million up front to use the company’s proprietary technology to discover and develop new drugs outside of the oncology space. The clinically validated platform—XTEN—is a proprietary unstructured polypeptide, which when attached to molecules, can extend the half-life of drugs with low associated immunogenicity, according to Amunix. As per the … Continue reading “Roche Pays $40M to Use Amunix Pharma’s Half-Life Extension Tech”
Allogene, SpringWorks to Test Drug Combo in Multiple Myeloma Trial
Springworks Therapeutics and Allogene Therapeutics have agreed to collaborate on a clinical trial to test a combination of an investigational cancer drug from each biotech in patients with multiple myeloma. The experimental treatment from Springworks, nirogacestat, is one of the four drug compounds that the company took off the Pfizer (NYSE: [[ticker:PFE]]) shelf when it … Continue reading “Allogene, SpringWorks to Test Drug Combo in Multiple Myeloma Trial”
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”
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”
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”
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”
DTx Pharma Raises $10.6M to Advance New Way to Deliver RNA Drugs
RNA medicines can treat some diseases by hitting targets otherwise considered “undruggable” by small molecules and biologics, but protecting the nucleic acids from degradation and getting the therapies to where they are needed in the body can be difficult. San Diego startup DTx Pharma has raised $10.6 million to advance technology it has developed that … Continue reading “DTx Pharma Raises $10.6M to Advance New Way to Deliver RNA 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”
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”
Empirico Raises $17M, Inks 3-Year Antisense Collaboration with Ionis
Empirico, a biotech that has developed tools to analyze genomics data and use those insights to identify potential therapeutic targets, has signed a collaboration deal with antisense drug developer Ionis Pharmaceuticals that includes a $10 million equity investment. The 14-person startup, founded in 2017, has developed technology that it says uses big data sets, human … Continue reading “Empirico Raises $17M, Inks 3-Year Antisense Collaboration with Ionis”
Novome Lands $33M to Tweak a Gut Microbe Into a Metabolic Therapy
Food gurus tout the benefits of eating spinach and kale, but some people are better off leaving them on the plate. A molecule in these leafy greens contributes to hyperoxaluria, a condition characterized by kidney stones at first and serious organ damage later. Novome Biotechnologies is developing a gut microbiome treatment for hyperoxaluria. The company … Continue reading “Novome Lands $33M to Tweak a Gut Microbe Into a Metabolic Therapy”
Mirati Adds Execs With Commercial Experience at Spark, Bristol-Myers
Cancer drug developer Mirati Therapeutics is beefing up its leadership team as its lead programs advance through human testing. The San Diego-based company (NASDAQ: [[ticker:MRTX]]) this week added two executives to its C-suite as part of a strategic effort to ready the biotech for its potential transformation into a commercial company. For San Diego, it’s … Continue reading “Mirati Adds Execs With Commercial Experience at Spark, Bristol-Myers”
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”
Apellis Rare Blood Disease Drug Tops Alexion’s in Head-to-Head Test
Apellis Pharmaceuticals wants to offer patients who have an ultra-rare blood disease another treatment option. The drug developer Tuesday revealed late-stage clinical trial data suggesting its experimental therapy works better than a blockbuster Alexion Pharmaceuticals medicine that is currently the standard of care. The Apellis (NASDAQ: [[ticker:APLS]]) drug, pegcetacoplan, is in testing as a treatment … Continue reading “Apellis Rare Blood Disease Drug Tops Alexion’s in Head-to-Head Test”
Takeda to Fund AI Projects at MIT as Part of New 3-Year Collaboration
Takeda is teaming up with MIT to advance projects intended to enhance its understanding of how to best use artificial intelligence to solve some of the biopharma industry’s biggest challenges. The Japanese company (NYSE: [[ticker:TAK]]) will fund six to 10 projects per year for three years. Financial terms of the agreement, which includes a potential … Continue reading “Takeda to Fund AI Projects at MIT as Part of New 3-Year Collaboration”
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”
BioIntervene Raises $30M to Move Nerve Pain Drug Into the Clinic
In the past seven years BioIntervene has been working to develop “ultra-selective” compounds to target an adenosine receptor associated with pain relief. Now the San Diego-based biotech has $30 million and a chief scientific officer, Charles Cohen, to guide its lead compound, BIO-205, into human testing for neuropathic pain. The company announced the Series A … Continue reading “BioIntervene Raises $30M to Move Nerve Pain Drug Into the Clinic”
Merck Ramps Up KRAS Chase Through Licensing Deal With Taiho, Astex
The KRAS gene has become a hot target for cancer research for a growing number of drug developers. Merck, which is already testing a KRAS vaccine candidate, is now spreading its bets with a licensing deal for small molecule KRAS drugs being developed by two Otsuka Pharmaceutical subsidiaries. Merck (NYSE: [[ticker:MRK]]) is paying $25 million … Continue reading “Merck Ramps Up KRAS Chase Through Licensing Deal With Taiho, Astex”
China’s CF PharmTech Raises $90M to Advance Respiratory Drug Development
The China-based pharmaceutical company CF PharmTech has raised $90 million to support its pipeline of respiratory drugs. The Series E investment round was led by New Alliance Capital. New investors CR-CP Life Science Fund, Finnova Capital, GT Capital, Co-stone Asset Management, Xiangcheng Financial Holdings, and Everest Venture Capital, joined earlier investors, including Oriza Holdings, Longmen … Continue reading “China’s CF PharmTech Raises $90M to Advance Respiratory Drug Development”
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”
After Antitrust Challenges, Illumina and PacBio Throw in Towel on Merger
DNA sequencing machine maker Illumina will have to find another way to “read” long pieces of genetic material as well as short stretches, the genomic giant’s bailiwick. Its $1.2 billion proposal to acquire long-read capability by buying rival Pacific Biosciences ended Thursday following challenges from antitrust regulators. The deal foundered about 14 months after the … Continue reading “After Antitrust Challenges, Illumina and PacBio Throw in Towel on Merger”
No More Fish or Fruit: Intrexon Turns SynBio Focus to Human Health
Intrexon has spent two decades designing and building DNA sequences for applications in healthcare, food, energy, and the environment. Going forward, the synthetic biology company will focus exclusively on human health under the name of a subsidiary whose lead cell therapies are now in early-stage clinical testing in cancer. Germantown, MD-based Intrexon (NASDAQ: [[ticker:XON]]) announced … Continue reading “No More Fish or Fruit: Intrexon Turns SynBio Focus to Human Health”
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”