Category: Today’s Highlights

Answering Readers Questions About the Possible Outcome of Valeant Pharmaceuticals’ Psoriasis Drug

Answering Readers Questions About the Possible Outcome of Valeant Pharmaceuticals’ Psoriasis Drug

The FDA advisory committee members’ inability to rule for or against the approval of Valeant (VRX) anti plaque psoriasis drug brodalumab was not unexpected. However, more outside observers were expecting the committee to flatly reject the skin disease drug that would subject people to commit suicide or to cardiovascular side effects, including death. Indeed, the discussions were mostly about the drug’s side effects specifically the …
Coming from AstraZeneca and Juno: News That Makes a Big Difference

Coming from AstraZeneca and Juno: News That Makes a Big Difference

Important news is the news that informs about successful achievements that make a difference in treating life-threatening diseases, chronic diseases and diseases with no available treatments. Sometime you might not have a personal interest in one, or another or even all the mentioned firms in the news. For investors in the biotech sector, however, it is good to know the successful treatments that might be …
The FDA Approves INSIGHTEC’s Non-Invasive Approach That Treats Tremors. Humans Can Make Miracles Too.

The FDA Approves INSIGHTEC’s Non-Invasive Approach That Treats Tremors. Humans Can Make Miracles Too.

The FDA approved INSIGHTEC firm’s Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication. Using focused ultrasound waves Exablate Neuro precisely targets and ablates tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement …
Why Amgen Is Still King. Why Roche Allergic Asthma Drug Xolair Is Becoming a Blockbuster.

Why Amgen Is Still King. Why Roche Allergic Asthma Drug Xolair Is Becoming a Blockbuster.

AMGEN Repatha is the human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR). The binding  prevents PCSK9-mediated LDLR degradation, permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs …
JUNO: The CAR-T Approach Is Still a Source of Hope for Cancer Patients Who Have Lost It

JUNO: The CAR-T Approach Is Still a Source of Hope for Cancer Patients Who Have Lost It

Juno Therapeutics (JUNO) announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the “ROCKET” trial. The clinical hold was initiated after patients’ death last week, which followed a recent addition of fludarabine to the pre-conditioning regimen. …
Oncolytic Adenovirus Plus Opdivo Could Be a Game Changer in Late Stage Cancer. See Also: Gossip Surrounds Tesaro

Oncolytic Adenovirus Plus Opdivo Could Be a Game Changer in Late Stage Cancer. See Also: Gossip Surrounds Tesaro

PsiOxus Therapeutics’ adenovirus product in combination with Opdivo (nivo-lumab) for late-stage cancers.     Bristol-Myers Squibb (BMY) and PsiOxus Therapeutics (PsiOxus) announced an agreement to evaluate PsiOxus’ drug enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Bristol-Myers Squibb’s checkpoint inhibitor opdivo (nivolumab) for a range of tumor types in late-stage cancer patients. Enadenotucirev is designed to have immune stimulating effects while Opdivo is designed …
Tesaro: The Time Has Come for Bringing Hope to Recurrent Ovarian Cancer Patients

Tesaro: The Time Has Come for Bringing Hope to Recurrent Ovarian Cancer Patients

- Tesaro's (TSRO) drug niraparib significantly improved progression-free survival for patients with ovarian cancer in both cohorts of the phase 3 NOVA trial - The NOVA trial successfully achieved its primary endpoint of PFS in the germline BRCA mutant cohort   - The NOVA trial successfully achieved its primary endpoint of PFS in the germline and non-germline BRCA mutant cohort. PFS endpoint is also achieved in …
Ignoring Incyte’s Successive Good News Will Fail to Mislead Investors

Ignoring Incyte’s Successive Good News Will Fail to Mislead Investors

GRAFT VERSUS HOST DISEASE (GVHD) INCYTE (INCY) HAS SEVERAL GOOD NEWS. As a matter of fact, Incyte has exciting news coming from innumerable activities strategized by the firm’s dynamic management. The first good news came from the FDA, granting Breakthrough Therapy Designation for Jakafi® (ruxolitinib) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for GVHD. Breakthrough Therapy …
Paratek Antibiotic Omadacycline Meets Primary Endpoint in Resistant Infection

Paratek Antibiotic Omadacycline Meets Primary Endpoint in Resistant Infection

Paratek Pharmaceuticals (PRTK) announced positive results from Phase 3 registration study comparing its once-daily, broad spectrum antibiotic, omadacycline, to linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The firm’s press release stated that its antibiotic drug met the FDA-specified primary efficacy endpoint of early clinical response. The study has also met the European Medicines Agency (EMA)-specified co-primary efficacy endpoints for …
Ariad Pharmaceuticals Submits Early NDA for the Approval of Brigatinib. See Also: More News from Ariad

Ariad Pharmaceuticals Submits Early NDA for the Approval of Brigatinib. See Also: More News from Ariad

ARIAD Pharmaceuticals (ARIA) announced the initiation of a New Drug Application (NDA) submission for brigatinib, the firm’s investigational anaplastic lymphoma kinase (ALK) inhibitor to the FDA. Earlier than expected, ARIAD is seeking U.S. marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib, which has received Breakthrough Therapy designation from the FDA for for this NSCLC condition …
Great News for Celator That Might Be Great News for Jazz Pharmaceuticals

Great News for Celator That Might Be Great News for Jazz Pharmaceuticals

CELATOR PHARMACEUTICALS Good News That Might Go to JAZZ Pharmaceuticals Celator Pharmaceuticals (CPXX): At the European Hematology Association (EHA) 21st Annual Congress, Celator  presented positive response rate results in acute myeloid leukemia (AML) patients with the FLT3 (FMS-like tyrosine kinase-3) mutation.   The results came from Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection in patients with high-risk (secondary) acute myeloid leukemia (AML). Data, …
At ASCO: Exelixis Has Great News for Cobimetyx on RCC

At ASCO: Exelixis Has Great News for Cobimetyx on RCC

Additional data from pivotal METEOR trial underscore clinically meaningful benefit of Exelixis’ (EXEL) drug Cabometyx™ for patients with Advanced RCC AT the ASCO Meeting: ABSTRACT #4557, #4558 Cabometyx’™ benefit was robust and consistent regardless of prior treatment, location and extent of tumor metastases Positive data will be presented at the 2016 American Society of Clinical Oncology (ASCO) from subgroup analyses of the pivotal METEOR trial. …
Theravance Biopharma and Mylan COPD Product is Speeding Towards Approval

Theravance Biopharma and Mylan COPD Product is Speeding Towards Approval

Enrollment has been completed in all the three ongoing clinical trials comprising the firm’s Phase 3 program for Theravance Biopharma’s (TBPH) revefenacin (TD-4208). The drug is an investigational long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD). The three revefenacin Phase 3 program are meant to support the registration of the product in the U.S. More than 2,300 patients have been enrolled and Top-line …
Accelerated FDA Approvals of Immunotherapy Treatments Are Accelerating

Accelerated FDA Approvals of Immunotherapy Treatments Are Accelerating

CANCER Everyday something new is discovered that explains cancer behavior, including proliferation, response to treatment, resistance to treatment, metastasis, recurrence, etc. Today we have several news, including one that might have cleared a puzzle regarding a continuous growth of colon cancer after oncologists block a well known signaling molecule recognized as playing a major role in making, not breaking the cancer. We also have news …
Portola: Solving the Huge Problem of the New Anticoagulants

Portola: Solving the Huge Problem of the New Anticoagulants

Notwithstanding the unrelenting improvements being constantly made in managing blood coagulation’s problems, conventional anticoagulants still have thrombotic incidents (clots) in patients taking anticoagulants (blood thinners) and bleeding remained the most feared side effect of these indispensable life-saving drugs. In recent years, several novel anticoagulants demonstrating obvious advantages over conventional anticoagulants have been created, developed and marketed. Their advantages over conventional anticoagulants have been validated through …
Disrupting the Capability of Cancer Cells to Repair Their Damaged DNA. See Also: Underestimated Biotech Firms

Disrupting the Capability of Cancer Cells to Repair Their Damaged DNA. See Also: Underestimated Biotech Firms

Underestimating the Value of Drugs that Disrupt the DNA Repair Mechanisms in Cancer Cells. AstraZeneca’s (AZN) Chief Executive Pascal Soriot said that while DNA damage response was under-recognized by investors, oncologists were already “very excited” by its potential of the drugs targeting DNA repair mechanisms inside cancer cells. According to AstraZeneca, drugs that disrupt the DNA repair mechanisms inside cancer cells are showing tangible promise for …
Giving to Gilead What Belongs to Gilead. Jazz Offers a Needed Relief

Giving to Gilead What Belongs to Gilead. Jazz Offers a Needed Relief

GILEAD After years of controversial refraining, official India reversed course and granted Gilead Sciences its patent rights to Sovaldi hepatitis C treatment. More than a victory for Gilead, it was the prevalence of fairness after years of underestimating the power to fairness to keep resurfacing until reinstated. The Indian Patent Office had rejected Gilead’s patent application based on a notion that it did not demonstrate …
Incyte Acquires Ariad Pharmaceuticals European Operations. See Also: A Great Achievement by Illumina

Incyte Acquires Ariad Pharmaceuticals European Operations. See Also: A Great Achievement by Illumina

By June, which is next month, Incyte (INCY) will be the owner of the European operations of Ariad (ARIA). That’s what both firms have announced yesterday. Among other details, the firms decided on signing a licensing agreement for exclusive development and commercialization rights to Ariad’s Iclusig (ponatinib) in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia. Iclusig is approved …
Who Will End Up Acquiring Medivation? Abbott Acquires St Jude. See Also: Alnylam

Who Will End Up Acquiring Medivation? Abbott Acquires St Jude. See Also: Alnylam

Medivation is a Target for Acquisition The Question is: Who Will Acquire Medivation? Sanofi has made a bid to acquire Medivation for $9.3 billion (£6.37B). Sanofi is expected to pay $52.50 per share in cash for Medivation. Why Medivation? Sanofi's chief executive Olivier Brandicourt said, "Thanks to Medivation's excellent prostate cancer treatments, we believe that a merger with Medivation would benefit patients and, at the same time, create value …
Agenus First Immune Check Protein Inhibitor in Clinical Trial. See Also: IMGN and EXEL

Agenus First Immune Check Protein Inhibitor in Clinical Trial. See Also: IMGN and EXEL

Biotech NEWS   AGENUS Agenus’ First Checkpoint Inhibitor to reach Clinical Trial The first patient has been dosed in Agenus (AGEN) Phase 1 clinical trial of its checkpoint inhibitor product AGEN1884. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the safety of AGEN1884 and determine the estimated maximum tolerated dose. AGEN1884 is an anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4) checkpoint …