Pharmacist Digest

STAT+: Amgen goes all in on injectable obesity drug as it scraps early-stage pill

STAT

MAY 2, 2024

Amgen said Thursday that it will no longer develop an early-stage obesity pill, and will instead focus on a more advanced injectable candidate that’s seen as a potential competitor to Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.

Diabetes

STAT+: In large trial, Guardant Health’s blood test detects colon cancer, but less reliably at earliest or precancerous stages

STAT

MARCH 13, 2024

In newly published clinical trial results, the Shield test caught colorectal cancer at stages 2 or later with 100% sensitivity — but it was far worse at detecting stage 1 cancer and did not reliably detect precancerous polyps. Those hopes were partially fulfilled on Wednesday.

STAT+: Vertex’s closely-watched pain relief drug succeeds in late-stage trials — with a catch

STAT

JANUARY 30, 2024

A pain relief drug developed by Vertex Pharmaceuticals succeeded in late-stage clinical trials, the company announced Tuesday, bringing the biopharma giant a step closer to launching what observers believe could be a potential blockbuster and upending decades of pharma failure in a complicated field.

Drug Development

STAT+: Vertex non-opioid drug reduces chronic nerve pain in mid-stage study

STAT

DECEMBER 13, 2023

Vertex Pharmaceuticals said Wednesday that an experimental drug reduced pain in people with diabetes who have chronic nerve pain — mid-stage study results that support the biotech company’s efforts to develop an effective painkiller without the addictive potential of opioids.

Diabetes

Nuvation Bio nears commercial stage with AnHeart buy

pharmaphorum

MARCH 26, 2024

Nuvation Bio speeds up its path to becoming a commercial-stage biotech with a deal to acquire AnHeart Therapeutics and its late-stage lung cancer therapy taletrectinib

STAT+: Shortage of monkeys for early-stage research jeopardizes timelines for developing some drugs

STAT

MARCH 29, 2023

A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development. In recent weeks, the U.S

Drug Development

STAT+: Ventyx stock craters after lackluster mid-stage trial results for psoriasis drug

STAT

NOVEMBER 6, 2023

SAN DIEGO — Ventyx Biosciences reported on Monday that it was ending development of an experimental drug for treating plaque psoriasis though it proved safe and moderately effective in a mid-stage trial. Within hours, the company’s stock tanked by more than 80%.

Drug Development

STAT+: AstraZeneca buys early-stage gene therapies from Pfizer in boon for struggling field

STAT

JULY 28, 2023

AstraZeneca said Friday it will buy up a group of early-stage gene therapies from Pfizer, bucking a trend of drugmakers axing programs and exiting a field that had once captured the imagination — and checkbooks — of many pharmaceutical executives. The companies did not say how much it is paying upfront.

Pandemic slowed cancer diagnoses, but late-stage cancers came back with a vengeance

STAT

AUGUST 4, 2023

Early-stage cancer diagnoses decreased by nearly 20% in the first year of the Covid-19 pandemic. A new study published in Lancet Oncology emphasizes how, because of disruptions in care, patients were more likely to get diagnosed with deadly metastatic disease — across nearly all cancer types.

STAT+: Akero treatment for NASH reduces liver scarring, achieves goals of mid-stage study

STAT

SEPTEMBER 13, 2022

Akero Therapeutics said Tuesday that an experimental medicine improved liver scarring at twice the rate of a placebo without worsening other symptoms — achieving the main goal of a mid-stage clinical trial involving patients with the fatty liver disease known as NASH.

STAT+: Moonlake’s credibility takes another hit with mid-stage study spin job

STAT

NOVEMBER 6, 2023

Moonlake claimed its experimental antibody called sonelokimab delivered “landmark” results in a mid-stage study of psoriatic arthritis. It’s been awhile since I encountered a management team that speaks so arrogantly about the supposed supremacy of its own drug, but then fails to back up the talk with real data.

STAT+: Mirum’s Chenodal succeeds in late-stage trial for rare metabolic disorder

STAT

OCTOBER 2, 2023

Mirum Pharmaceuticals reported on Monday that a drug it recently acquired to treat cerebrotendinous xanthomatosis, a rare and serious disease in which the body doesn’t metabolize cholesterol properly, succeeded in a late-stage trial.

Drug Development

STAT+: Crinetics acromegaly drug succeeds in late-stage trial but would face stiff competition if approved

STAT

SEPTEMBER 10, 2023

SAN DIEGO — Crinetics Pharmaceuticals announced on Sunday that its experimental drug for acromegaly, a rare and serious hormonal disorder, succeeded in a late-stage trial, bringing the San Diego biotech a step closer to applying for Food and Drug Administration approval — and entry into a crowded market with blockbuster therapies sold (..)

STAT+: Late-stage trial supports broader use of Darzalex, blockbuster J&J multiple myeloma drug

STAT

DECEMBER 12, 2023

Now results from a late-stage trial announced Tuesday during this year’s meeting of the American Society of Hematology offer evidence to support broader use of the drug. SAN DIEGO — Johnson & Johnson’s multiple myeloma therapy, Darzalex, is already a blockbuster.

Immunity

Immunity Immunization

Is CAR-T safe for early-stage patients?

STAT

MARCH 14, 2024

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, everyone.

STAT+: Prometheus’ inflammatory bowel drug succeeds in two mid-stage trials

STAT

DECEMBER 7, 2022

An investigative medicine from Prometheus Biosciences met its goals in a pair of Phase 2 studies enrolling patients with inflammatory bowel disease, setting the stage for pivotal trials and nearly doubling the company’s stock price. for the placebo group, the company said.

Labelling

FDA approves Alzheimer’s drug shown to moderately slow cognitive decline in early stages of the disease

STAT

JANUARY 6, 2023

The Food and Drug Administration on Friday approved a new Alzheimer’s disease treatment that moderately slows cognitive decline in people with early-stage disease. Read the rest…

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies Drug Pricing

Takeda grabs late-stage haematology drug from Protagonist

pharmaphorum

FEBRUARY 1, 2024

Takeda licenses late-stage polycythemia vera drug candidate rusfertide from Protagonist Therapeutics, adding to its rare blood disorder pipeline.

STAT+: Lilly’s obesity pill cuts 15% of weight at highest dose in mid-stage trial

STAT

JUNE 23, 2023

The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. SAN DIEGO – An experimental pill from Eli Lilly led to 14.7%

Diabetes

Diabetes Drug Development

STAT+: Ionis inches toward first solo drug launch with late-stage trial success for rare genetic disease therapy

STAT

SEPTEMBER 26, 2023

Ionis Pharmaceuticals, a California biotech that has spearheaded the development of RNA-targeting medicines, announced on Tuesday that its drug against familial chylomicronemia syndrome, a rare and serious disease that prevents the body from breaking down fats, succeeded in a late-stage clinical trial.

Drug Development

AstraZeneca to acquire Amolyt Pharma, expanding late-stage rare disease pipeline

World Pharma News

MARCH 14, 2024

AstraZeneca announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases.

STAT+: One in five primary endpoints changed in late-stage trials of cancer drugs already underway, study finds

STAT

MAY 19, 2023

Amid increased concerns over a lack of transparency in clinical trials, a new study found that one in five primary endpoints were changed after a late-stage study had begun, and 70% of the trials examined did not include information about primary endpoint changes in articles published in medical journals.

STAT+: ‘I never realized what people go through’: Doctor and former hospital CEO with Stage 4 cancer calls for greater empathy in medicine

STAT

NOVEMBER 14, 2023

But they couldn’t have known — along with most of the people in Fanale’s professional orbit — that he was battling Stage 4 lung cancer. Fellow runners encouraged him to “keep trying” whenever he slowed down.

Hospitals

After early-stage breast cancer, interrupting endocrine therapy to become pregnant didn’t raise risk of recurrence

STAT

MAY 3, 2023

Women with early-stage, hormone receptor-positive breast cancer who interrupted their endocrine therapy to become pregnant had about the same risk of cancer recurrence as similar breast cancer patients who didn’t pause their treatment, the study found.

STAT+: Several years later, AstraZeneca says its drug extends life for some early-stage lung cancers

STAT

MARCH 10, 2023

Ever since the Food and Drug Administration approved osimertinib for some early-stage lung cancer patients to take after surgery, clinicians have debated whether the evidence suggested the drug was worth the cost.

The 5 Stages of Hashimoto’s Thyroiditis

The Thyroid Pharmacist

AUGUST 12, 2022

Hashimoto’s is not usually discovered until it has progressed to the advanced stages, where there is significant damage to the thyroid gland. In this article, I’d like to start at the beginning and walk through the stages of Hashimoto’s. The 5 stages of Hashimoto’s. Hashimoto’s Stages. Stage 1: Genetic Predisposition.

Immunity

Immunity Immunization Adverse Reactions

Vaccines in late-stage development hold promise in tackling disease burden: GlobalData

Express Pharma

MARCH 21, 2024

Vaccines in late-stage development hold promise in containing the disease burden, says GlobalData. According to GlobalData, there are 11 vaccines in late-stage development* for TB globally. - conveys the message that there is hope in making this a possibility. Focusing on prevention and early diagnosis are key to achieving this goal.

Vaccines

STAT+: Gilead, Arcus anti-TIGIT drug reduces risk of lung cancer progression in mid-stage study

STAT

DECEMBER 19, 2022

Gilead Sciences and Arcus Biosciences said Monday that an experimental cancer immunotherapy directed against a target called TIGIT reduced the risk of tumor progression or death by 45% in a mid-stage clinical trial involving patients with lung cancer.

Merck grabs late-stage oncology drug from China’s Abbisko

pharmaphorum

DECEMBER 4, 2023

Merck grabs late-stage oncology drug from China’s Abbisko Phil.Taylor Mon, 04/12/2023 - 16:19 Bookmark this

How to advance more late-stage neuroscience drugs to regulatory approval

pharmaphorum

DECEMBER 1, 2023

How to advance more late-stage neuroscience drugs to regulatory approval Mike.Hammerton Fri, 01/12/2023 - 09:00 Bookmark this

STAT+: Machine learning biotech raises $273 million in rare successful late-stage round

STAT

SEPTEMBER 14, 2023

Biotech startup Generate Biomedicines, which uses artificial intelligence to find new drugs, raised $273 million in a Series C funding round from investors including pharma company Amgen and the VC arm of AI giant NVIDIA.

STAT+: Breast cancer drug from AstraZeneca, Daiichi hits goal in late-stage trial

STAT

SEPTEMBER 22, 2023

LONDON — AstraZeneca said Friday an experimental drug tamped down the progression of a certain type of breast cancer in a Phase 3 trial, a win for the company after the same drug produced underwhelming results in a lung cancer trial over the summer.

Chemotherapy

Takeda speeds narcolepsy drug to late-stage testing

BioPharma Dive

FEBRUARY 9, 2024

New results have convinced Takeda to “rapidly” pursue a late-stage program for its drug TAK-861 in one type of narcolepsy, while in another the company opted not to continue.

Xtandi cleared by FDA for earlier-stage prostate cancer

pharmaphorum

NOVEMBER 17, 2023

Xtandi cleared by FDA for earlier-stage prostate cancer Phil.Taylor Fri, 17/11/2023 - 11:19 Bookmark this

STAT+: Anthos stroke drug appears safer than common blood thinner in mid-stage trial

STAT

NOVEMBER 12, 2023

PHILADELPHIA — An investigational drug aimed at preventing strokes significantly reduced the risk of bleeding compared with a commonly used blood thinner for stroke prevention, showing potential to be a safer alternative for patients.

BGF investment for early-stage businesses

Pharma Times

FEBRUARY 17, 2023

Company has reported strong momentum among the early-stage businesses it invested in last year

Roche seeks early-stage lung cancer use for Alecensa

pharmaphorum

SEPTEMBER 4, 2023

Roche seeks early-stage lung cancer use for Alecensa Phil.Taylor Mon, 04/09/2023 - 09:03 Bookmark this

EU clears review of Xtandi in earlier-stage prostate cancer

pharmaphorum

SEPTEMBER 13, 2023

EU clears review of Xtandi in earlier-stage prostate cancer Phil.Taylor Wed, 13/09/2023 - 09:55 Bookmark this

STAT+: Pharmalittle: Pfizer scaling back early-stage research into rare diseases; BioNTech and U.K. partner on cancer trials

STAT

JANUARY 6, 2023

… Pfizer told employees it plans to pull back on early-stage research into treatments for rare diseases, including the development of new viral-based gene therapies , Barron’s reports. Enjoy, and see you soon.

Staging of Renal Function

RX Note

SEPTEMBER 8, 2023

Staging of CKD is done according to Cause of disease 6 categories of GFR (G stages) 3 categories of albuminuria (A stages) NOTE: The term "end-stage kidney disease" (ESKD) generally refers to chronic kidney failure treated with either dialysis or transplantation. More advanced tools (e.g.

Dosage

Dosage Diabetes Communication

Lilly’s donanemab will face an Alzheimer’s adcomm in June, setting the stage for a Leqembi showdown

PharmaVoice

MAY 9, 2024

The FDA announced a June advisory committee date, potentially introducing a new Alzheimer’s treatment to compete with Eisai and Biogen’s Leqembi.

STAT+: With an old approach but new energy, ADCs take center stage as promising cancer treatments

STAT

OCTOBER 24, 2023

MADRID — If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting , a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates.

Compounding

Compounding Drug Development

Novartis adds clinical-stage protein degrader from Arvinas

pharmaphorum

APRIL 11, 2024

Novartis accelerates its protein degrader programmes by licensing a phase 3-ready prostate cancer candidate from Arvinas in a deal worth over $1 billion

STAT+: KalVista pill reduces swelling symptoms caused by genetic disease, achieving goal of late-stage study

STAT

FEBRUARY 13, 2024

KalVista Pharmaceuticals said Tuesday that its oral, on-demand treatment for the swelling “attacks” commonly experienced by patients with a genetic condition called hereditary angioedema achieved the goals of a Phase 3 clinical trial.

Drug Development

STAT+: Amgen goes all in on injectable obesity drug as it scraps early-stage pill

STAT+: In large trial, Guardant Health’s blood test detects colon cancer, but less reliably at earliest or precancerous stages

Trending Sources

STAT+: Vertex’s closely-watched pain relief drug succeeds in late-stage trials — with a catch

STAT+: Vertex non-opioid drug reduces chronic nerve pain in mid-stage study

Nuvation Bio nears commercial stage with AnHeart buy

STAT+: Shortage of monkeys for early-stage research jeopardizes timelines for developing some drugs

STAT+: Ventyx stock craters after lackluster mid-stage trial results for psoriasis drug

STAT+: AstraZeneca buys early-stage gene therapies from Pfizer in boon for struggling field

Pandemic slowed cancer diagnoses, but late-stage cancers came back with a vengeance

STAT+: Akero treatment for NASH reduces liver scarring, achieves goals of mid-stage study

STAT+: Moonlake’s credibility takes another hit with mid-stage study spin job

STAT+: Mirum’s Chenodal succeeds in late-stage trial for rare metabolic disorder

STAT+: Crinetics acromegaly drug succeeds in late-stage trial but would face stiff competition if approved

STAT+: Late-stage trial supports broader use of Darzalex, blockbuster J&J multiple myeloma drug

Is CAR-T safe for early-stage patients?

STAT+: Prometheus’ inflammatory bowel drug succeeds in two mid-stage trials

FDA approves Alzheimer’s drug shown to moderately slow cognitive decline in early stages of the disease

Takeda grabs late-stage haematology drug from Protagonist

STAT+: Lilly’s obesity pill cuts 15% of weight at highest dose in mid-stage trial

STAT+: Ionis inches toward first solo drug launch with late-stage trial success for rare genetic disease therapy

AstraZeneca to acquire Amolyt Pharma, expanding late-stage rare disease pipeline

STAT+: One in five primary endpoints changed in late-stage trials of cancer drugs already underway, study finds

STAT+: ‘I never realized what people go through’: Doctor and former hospital CEO with Stage 4 cancer calls for greater empathy in medicine

After early-stage breast cancer, interrupting endocrine therapy to become pregnant didn’t raise risk of recurrence

STAT+: Several years later, AstraZeneca says its drug extends life for some early-stage lung cancers

The 5 Stages of Hashimoto’s Thyroiditis

Vaccines in late-stage development hold promise in tackling disease burden: GlobalData

STAT+: Gilead, Arcus anti-TIGIT drug reduces risk of lung cancer progression in mid-stage study

Merck grabs late-stage oncology drug from China’s Abbisko

How to advance more late-stage neuroscience drugs to regulatory approval

STAT+: Machine learning biotech raises $273 million in rare successful late-stage round

STAT+: Breast cancer drug from AstraZeneca, Daiichi hits goal in late-stage trial

Takeda speeds narcolepsy drug to late-stage testing

Xtandi cleared by FDA for earlier-stage prostate cancer

STAT+: Anthos stroke drug appears safer than common blood thinner in mid-stage trial

BGF investment for early-stage businesses

Roche seeks early-stage lung cancer use for Alecensa

EU clears review of Xtandi in earlier-stage prostate cancer

STAT+: Pharmalittle: Pfizer scaling back early-stage research into rare diseases; BioNTech and U.K. partner on cancer trials

Staging of Renal Function

Lilly’s donanemab will face an Alzheimer’s adcomm in June, setting the stage for a Leqembi showdown

STAT+: With an old approach but new energy, ADCs take center stage as promising cancer treatments

Novartis adds clinical-stage protein degrader from Arvinas

STAT+: KalVista pill reduces swelling symptoms caused by genetic disease, achieving goal of late-stage study

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