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”

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”

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”

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”

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”

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”

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”

Eli Lilly Veteran Enrique Conterno Named FibroGen CEO

Enrique Conterno, a 27-year veteran of Eli Lilly, has been appointed CEO of FibroGen (NASDAQ: [[ticker:FGEN]]). He is also joining the San Francisco company’s board of directors. Conterno retired from Lilly last year, where he was most recently president of Lilly USA. In his new role Conterno takes over from Jim Schoeneck, FibroGen’s interim CEO … Continue reading “Eli Lilly Veteran Enrique Conterno Named FibroGen CEO”

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”

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”

Aridis Promotes Michael Nazak to Chief Financial Officer

Aridis Pharmaceuticals (NASDAQ: [[ticker:ARDS]]) has appointed Michael Nazak to the role of chief financial officer. He succeeds Fred Kurland, who has retired but will continue working with the San Jose, CA-based company as a consultant. Nazak joined Aridis in late 2018 as the vice president of finance. Previously, he served as senior vice president of … Continue reading “Aridis Promotes Michael Nazak to Chief Financial Officer”

Encoded Makes Chief Regulatory, People & Culture Officer Appointments

Encoded Therapeutics added two people to its C-suite this week. The South San Francisco-based company named Nancy Boman as its chief regulatory officer and Monique Bobadilla as its chief people and culture officer. Encoded, which raised $104 million in June, aims to develop gene therapies to treat diseases the technique currently can’t address. Its lead … Continue reading “Encoded Makes Chief Regulatory, People & Culture Officer Appointments”

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”

Triplet Therapeutics Unveils $59M to Try Hairpin Fix for Huntington’s

Huntington’s disease drug research has focused mainly on the genetic roots of the rare neurodegenerative disorder. Triplet Therapeutics is taking a different tack by targeting a DNA repair mechanism gone awry, an approach that CEO Nessan Bermingham says could offer a better way to treat that disease and potentially dozens of others. Cambridge, MA-based Triplet … Continue reading “Triplet Therapeutics Unveils $59M to Try Hairpin Fix for Huntington’s”

Grail Appoints Illumina’s Gautam Kollu as Chief Commercial Officer

Grail, the Illumina (NASDAQ: [[ticker:ILMN]]) spinout that has raised more than $1.5 billion to advance its development of a blood test for early detection of cancer, has appointed Gautam Kollu as its chief commercial officer. Kollu joins the company from its parent firm, where he was vice president of global market development. His prior experience … Continue reading “Grail Appoints Illumina’s Gautam Kollu as Chief Commercial Officer”

Alector Appoints Suliman President & Chief Operating Officer

Shehnaaz Suliman has been appointed president and chief operating officer of Alector (NASDAQ: [[ticker:ALEC]]). She joins the South San Francisco biotech from Theravance Biopharma, where she was senior vice president of corporate development and strategy. Her experience also includes positions at Genentech, Roche Partnering, and Gilead Sciences (NASDAQ: [[ticker:GILD]]). Alector is developing drugs that target … Continue reading “Alector Appoints Suliman President & Chief Operating Officer”

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”

BridgeBio Pharma Onboards Eli Wallace to Lead Oncology Programs

Palo Alto, CA-based BridgeBio Pharma (NASDAQ: [[ticker:BBIO]]) has named Eli Wallace as its chief scientific officer in residence for oncology. In this role, Wallace will oversee the company’s current drug discovery projects, while helping identify and develop new oncology programs. Wallace has more than two decades of experience and was most recently the chief scientific … Continue reading “BridgeBio Pharma Onboards Eli Wallace to Lead Oncology Programs”

Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More

It’s been a roller-coaster year for those hoping for new drugs to treat Alzheimer’s disease, a leading cause of death with rising treatment costs and no clear answer yet as to its cause. Clearing proteins, such as amyloid and tau, was once seen as the top contender for stopping or slowing neurodegeneration. Costly failures forced … Continue reading “Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More”

Nektar Therapeutics Names John Northcott Chief Commercial Officer

John Northcott has joined Nektar Therapeutics (NASDAQ: [[ticker:NKTR]]) in the newly created role of senior vice president and chief commercial officer. Northcott was most recently the chief commercial officer of AbbVie (NYSE: [[ticker:ABBV]]) subsidiary Pharmacyclics. His experience also includes positions at Roche’s Genentech unit, Lexicon Pharmaceuticals (NASDAQ: [[ticker:LXRX]]), Merck (NYSE: [[ticker:MRK]]), and Pfizer (NYSE: [[ticker:PFE]]). … Continue reading “Nektar Therapeutics Names John Northcott Chief Commercial Officer”

Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption

Editor’s note: This is Part 2 of a two-part post about innovation in digital health, co-authored by Rob Coppedge, CEO of Echo Health Ventures. Read Part 1 here. The Path Forward Between Echo Health Ventures and Blue Cross and Blue Shield of North Carolina, we work deeply on both sides of these partnerships and have perspective … Continue reading “Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption”

Roche Notches FDA Nod in Lung Cancer, Amps Up Competition With Merck

A Roche immunotherapy has won an additional FDA approval as a first-line treatment for non-small lung cancer, bolstering the product’s competitive stance versus one from Merck. The FDA approved atezolizumab (Tecentriq) for adults whose non-squamous non-small cell lung cancer (NSCLC) is metastatic, meaning it has spread, and does not have the EGFR or ALK genetic … Continue reading “Roche Notches FDA Nod in Lung Cancer, Amps Up Competition With Merck”

Stemonix, Atomwise Team Up on Drug Discovery With MicroOrgans and AI

Two venture-backed startups that have developed technologies intended to speed up the drug discovery and development process are combining those tools in a bid to achieve their goals together. San Francisco-based Atomwise has developed deep learning techniques for use in structure-based small molecule drug discovery. Since 2012 it has raised more than $50 million to … Continue reading “Stemonix, Atomwise Team Up on Drug Discovery With MicroOrgans and AI”

Veracyte Aims to Expand Diagnostics Reach With $50M NanoString Deal

[Updated 12/4/19, 4:01 p.m. ET. See below.] Veracyte, a company whose tests help physicians make treatment decisions, is adding technology from NanoString to the fold to expand its diagnostic capabilities. South San Francisco-based Veracyte (NASDAQ: [[ticker:VCYT]]) announced Tuesday that it has reached a deal for global rights to develop and commercialize diagnostics based on the … Continue reading “Veracyte Aims to Expand Diagnostics Reach With $50M NanoString Deal”

Partner or Die: How to Succeed Even After the Digital Health Hype Quiets Down

Editor’s note: This is Part 1 of a two-part piece on innovation in digital health, co-authored by Bryony Winn, chief strategy and innovation officer at Blue Cross and Blue Shield of North Carolina. Read Part 2 here. More than 6,500 people descended on HLTH in Las Vegas in late October to “solve the most pressing … Continue reading “Partner or Die: How to Succeed Even After the Digital Health Hype Quiets Down”

Astellas Bets On Gene Therapy With $3B Audentes Acquisition Offer

Japanese drug giant Astellas Pharma announced late Monday it has agreed to buy Audentes Therapeutics, which is developing gene therapies for rare neuromuscular diseases. It’s an all-cash deal worth $3 billion, with the Astellas offer of $60 per share representing a 110 percent premium to Audentes’ (NASDAQ: [[ticker:BOLD]]) share price of $28.61 apiece at market close … Continue reading “Astellas Bets On Gene Therapy With $3B Audentes Acquisition Offer”

Curtis Ruegg to Succeed Amphivena Founder As New CEO, President

Curtis Ruegg will join Amphivena Therapeutics as president and CEO as the company’s founder Jeanmarie Guenot transitions to an advisory role. The San Francisco company, which has raised $88.5 million from outside investors, is is developing a type of immunotherapy called T cell engagers. Ruegg joins Amphivena from Parvus Therapeutics, where he held the same … Continue reading “Curtis Ruegg to Succeed Amphivena Founder As New CEO, President”

Global Blood’s Sickle Cell Drug Wins FDA Approval Ahead of Schedule

The FDA on Monday approved a Global Blood Therapeutics treatment for sickle cell disease, three months before the agency’s decision was expected. Regulators evaluated the drug, voxelotor (Oxbryta), under a pathway that allows for a speedier review using less evidence than is typically required. This pathway is reserved for drugs that address an unmet medical … Continue reading “Global Blood’s Sickle Cell Drug Wins FDA Approval Ahead of Schedule”

Ferring and Blackstone Team Up to Fund Gene Therapy Firm With $570M

Ferring Pharmaceuticals and Blackstone Life Sciences have formed a new company to commercialize a bladder cancer gene therapy that is currently in late-stage clinical testing. The new company, FerGene, is a subsidiary of Swiss pharmaceutical company Ferring, which is investing $170 million in the new unit. Blackstone has committed $400 million. In addition to US … Continue reading “Ferring and Blackstone Team Up to Fund Gene Therapy Firm With $570M”

Five Questions With a16z’s Vijay Pande on AI and Making New Drugs

In startup world these days, the word “biotech” is increasingly accompanied by “computational” and two, two-letter initialisms: AI and ML. Those tools—artificial intelligence and machine learning, respectively—have been around for decades, but in recent years have become faster and cheaper, accelerating their use by those in the business of discovering and developing new drugs. Another … Continue reading “Five Questions With a16z’s Vijay Pande on AI and Making New Drugs”

Immune-Onc Therapeutics Adds Paul Woodard and An Song to C-Suite

Paul Woodard has joined Immune-Onc Therapeutics as its chief medical officer. He comes to the Palo Alto, CA-based cancer immunotherapy developer from Bellicum Pharmaceuticals (NASDAQ: [[ticker:BLCM]]), where he was senior vice president of clinical and medical affairs. In other moves, Immune-Onc promoted An Song to chief scientific officer. Song was the company’s senior vice president … Continue reading “Immune-Onc Therapeutics Adds Paul Woodard and An Song to C-Suite”

Bio Roundup: So Long Celgene, RNAi’s Arrival, Pharma in 2020 & More

Bristol-Myers Squibb this week completed its acquisition of Celgene, a $74 billion deal that creates a pharmaceutical juggernaut. And all it took was the largest asset sale ever required by federal antitrust regulators. As the Federal Trade Commission reviewed Bristol’s (NYSE: [[ticker:BMS]]) deal to acquire Celgene, anti-inflammatory drug apremilast (Otezla) emerged as a sticking point. … Continue reading “Bio Roundup: So Long Celgene, RNAi’s Arrival, Pharma in 2020 & More”

Twist Bioscience Promotes Patrick Finn to Chief Commercial Officer

Twist Bioscience (NASDAQ: [[ticker:TWST]]), a synthetic biology company that has developed a proprietary way of manufacturing DNA by “writing” it on a silicon chip, has promoted Patrick “Paddy” Finn to chief commercial officer, a newly created position. Previously Finn, who joined Twist in 2015, was senior vice president of commercial operations. Prior to Twist he … Continue reading “Twist Bioscience Promotes Patrick Finn to Chief Commercial Officer”

Kronos Bio Appoints Jorge DiMartino as Its Chief Medical Officer

Kronos Bio has named Jorge DiMartino as its chief medical officer and executive vice president, clinical development, a newly created position. DiMartino, who was most recently at Celgene as vice president, translational development, will be based at Kronos headquarters in San Mateo, CA. Kronos, which aims to use its Small Molecule Microarray technology to develop … Continue reading “Kronos Bio Appoints Jorge DiMartino as Its Chief Medical Officer”

Liquid Biopsy Firm Lucence Plans Bay Area Buildout With $20M in Tow

Lucence, a genomic medicine company developing blood-based tests for cancer screening and treatment selection, announced this week the close of a $20 million Series A funding round led by IHH Healthcare. CEO and founder Min-Han Tan (pictured) says the investment will be used to scale the Singapore-based company’s clinical lab operations—notably in the US, with … Continue reading “Liquid Biopsy Firm Lucence Plans Bay Area Buildout With $20M in Tow”

Biopharma Execs Remain Optimistic Despite Political Headwinds

Drug pricing debates and uncertainty associated with Brexit are the issues most likely to keep biopharmaceutical executives awake at night. Nevertheless, senior figures remain optimistic about the industry’s prospects in 2020. These are among the major findings of a survey of 500 industry leaders and investors conducted by investment bank Jefferies. “Nearly half of respondents … Continue reading “Biopharma Execs Remain Optimistic Despite Political Headwinds”

Myovant to Seek FDA OK on Pill to Treat Advanced Prostate Cancer

A drug candidate once shelved by Takeda Pharmaceutical (NYSE: [[ticker:TAK]]) has found new life within Roivant Sciences spinout Myovant as a potential once-daily oral hormone therapy for patients with advanced prostate cancer. The Brisbane, CA-based biotech company (MYSE: [[ticker:MYOV]]) reported Tuesday that the drug, relugolix, met the primary goal of a Phase 3 trial, lowering … Continue reading “Myovant to Seek FDA OK on Pill to Treat Advanced Prostate Cancer”

Underdog Launches With $4M to Target “Toxic” Form of Cholesterol

Underdog Pharmaceuticals has launched with nearly $4 million in seed funding to develop treatments for atherosclerosis, a progressive condition in which arteries become clogged with substances such as fats and cholesterol, which restricts blood flow. Based in Mountain View, CA, Underdog is a spinout of the nonprofit SENS Research Foundation (SRF). Matthew O’Connor and Michael … Continue reading “Underdog Launches With $4M to Target “Toxic” Form of Cholesterol”

Alkermes Eyes Brain Disorders and Beyond With $100M Deal for Rodin

[Updated 5:55 p.m. See below.] Rodin Therapeutics has limited data from human studies about its neurodegeneration drug, but the company’s new approach to treating brain disorders has proven attractive enough for Alkermes to plunk down $100 million to buy the startup. According to financial terms announced Monday, the cash sum is an upfront payment. Depending … Continue reading “Alkermes Eyes Brain Disorders and Beyond With $100M Deal for Rodin”

Biotech Roundup: Gottlieb v. Juul, Solid Slumps, Avidity Gets $100M & More

Lung injuries connected to the use of electronic cigarettes have topped 2,000 and killed 40 people, according to the Centers for Disease Control and Prevention. It’s still unclear whether the cases are tied to legally sold products or devices modified by e-cigarette users, but the CDC this week identified a “potential toxin of concern”—Vitamin E … Continue reading “Biotech Roundup: Gottlieb v. Juul, Solid Slumps, Avidity Gets $100M & More”

Daré to Add Microchip-Based Birth Control to Women’s Health Portfolio

The list of activities our smartphones can control grows daily. Transfer money? It’s simple. Order groceries? That, too. Turn off the bedroom lights? Check. How about contraception? Advancing new forms of birth control is a central focus at Daré Bioscience (NASDAQ: [[ticker:DARE]]), a San Diego-based biopharma company that’s built a pipeline of experimental devices and … Continue reading “Daré to Add Microchip-Based Birth Control to Women’s Health Portfolio”

Startup X-37 Raises $14.5M to Expand on AI-Powered Drug Discovery

Launched just last year, artificial intelligence-powered drug discovery company X-37 now has raised $14.5 million in Series A financing to expand its development programs. Co-founded by Atomwise and a team from Velocity Pharmaceutical Development, the San Francisco, CA-based company uses Atomwise’s AI platform for structure-based drug design to screen chemical compounds against pharmaceutical targets. DCVC … Continue reading “Startup X-37 Raises $14.5M to Expand on AI-Powered Drug Discovery”