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Eskayef Pharmaceuticals Becomes Third Bangladeshi Company to Receive US FDA Approval for Manufacturing Facility

Drug Approval
  • Eskayef Pharmaceuticals Ltd received US FDA approval for its solid manufacturing facility in Tongi, Gazipur, becoming the third Bangladeshi pharmaceutical company to achieve this milestone after Square and Beximco Pharma.
  • The approval enables Eskayef to export Pregabalin capsules in eight different strengths (25mg to 300mg) to the US market, with the anti-epileptic and neuropathic pain medication set to launch shortly.
  • This achievement follows more than five years of efforts and represents a significant step toward Bangladesh's pharmaceutical export growth, which reached $169 million in 2020-21, more than doubling from $83 million five years earlier.
  • The FDA approval validates Eskayef's manufacturing quality standards and opens doors to the world's largest pharmaceutical market, reinforcing the company's global presence across 67 countries.

Moderna's COVID-19 Vaccine Spikevax Receives Full FDA Approval, Marking Company's First Licensed Product

Drug Approval
  • Moderna's COVID-19 vaccine Spikevax received full FDA approval for individuals 18 years and older, becoming the company's first licensed product in the United States.
  • The approval was based on clinical trial data showing 93% efficacy in preventing COVID-19 and 98% effectiveness in preventing severe disease among 28,451 participants.
  • Spikevax has now received regulatory approval in more than 70 countries, with Moderna having shipped 807 million doses globally in 2021.
  • The vaccine maintains the same formulation as the emergency-use authorization version and is administered as a two-dose primary series one month apart.

Polatuzumab Vedotin Shows Superior Efficacy in First-Line DLBCL Treatment and Confirms Long-Term Benefits in Relapsed Disease

Monoclonal AntibodyDrug Approval
  • The phase 3 POLARIX trial demonstrated that polatuzumab vedotin plus R-CHP (pola-R-CHP) significantly improved progression-free survival compared to standard R-CHOP in previously untreated DLBCL patients, reducing the risk of disease progression by 27%.
  • Long-term follow-up data from the GO29365 study confirmed durable disease control with polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL, with 25% of patients achieving ongoing responses lasting over 2 years.
  • Both studies showed manageable safety profiles for polatuzumab vedotin combinations, with peripheral neuropathy rates comparable to standard regimens and no new safety signals identified with extended follow-up.

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

NCT02257567CompletedPhase 1
Hoffmann-La Roche
Posted 10/15/2014

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

NCT03274492Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/16/2017

Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04665765Active, Not RecruitingPhase 2
City of Hope Medical Center
Posted 1/18/2021

A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma

NCT04332822RecruitingPhase 3
Nordic Lymphoma Group
Posted 8/19/2020

A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT04182204CompletedPhase 3
Hoffmann-La Roche
Posted 2/7/2020

FDA Approves First Eye Drops for Presbyopia Treatment, Offering Alternative to Reading Glasses

Drug Approval
  • The FDA has approved Vuity (pilocarpine HCl ophthalmic solution) 1.25% as the first prescription eye drops to treat presbyopia in adults, potentially benefiting an estimated 128 million Americans with this age-related vision condition.
  • Clinical trials involving 750 participants aged 40-55 demonstrated that Vuity works within 15 minutes and lasts up to six hours, allowing patients to read three or more additional lines on vision charts without compromising distance vision.
  • The drops use pilocarpine to reduce pupil size and increase depth of field, with side effects limited to headaches and eye redness in less than 5% of patients during Phase III studies.
  • Allergan/AbbVie's approval was based on two pivotal Phase III studies (GEMINI 1 and GEMINI 2) that met primary endpoints for improved near vision in low-light conditions versus placebo on day 30.

FDA Approves Insightec's Exablate Neuro for Advanced Parkinson's Disease Treatment

Drug Approval
  • The FDA has approved Insightec's Exablate Neuro focused ultrasound system for treating advanced Parkinson's disease patients with mobility, rigidity, or dyskinesia symptoms through incisionless pallidotomy.
  • The treatment uses focused ultrasound waves to precisely target and ablate the globus pallidus without requiring brain implants or surgical incisions, reducing infection risk compared to invasive surgery.
  • This approval expands the device's indications beyond essential tremor and tremor-dominant Parkinson's disease, with 37 medical centers in the US currently using the technology.
  • Parkinson's disease affects an estimated one million patients in the United States, with the new approval providing a less invasive surgical option when medications are not well tolerated.

ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

NCT01772693CompletedNot Applicable
InSightec
Posted 9/1/2012

Real-World Evidence Increasingly Influences FDA Drug Approvals, Study Finds

Real World EvidenceDrug Approval
  • A systematic review of FDA approval documents from 2019-2021 found that 85% of new drug and biologic approvals incorporated real-world evidence (RWE) in some form, with the proportion increasing from 75% in 2019 to 96% in the first half of 2021.
  • Among 88 approvals that included RWE studies intended to support safety or effectiveness, 74% influenced FDA's benefit-risk assessment, with 9% serving as substantial or primary evidence and 65% providing supportive evidence.
  • FDA's documented feedback on RWE studies highlighted common issues including methodological problems, sample size concerns, and omission of patient-level data, emphasizing the importance of fit-for-purpose data selection and rigorous study design.

FDA Approves Breakthrough Twice-Yearly HIV Prevention Drug Lenacapavir with Nearly 100% Efficacy

Drug Approval
  • The FDA has approved lenacapavir, a breakthrough preventative treatment for HIV that offers nearly 100 percent protection from the virus and could change the course of the AIDS epidemic.
  • The new drug represents a significant advancement in HIV prevention with its twice-yearly dosing schedule, potentially improving patient adherence compared to daily prevention medications.
  • Despite the promising therapeutic breakthrough, deep cuts to health initiatives could hinder the rollout of this potentially game-changing HIV prevention treatment.

FDA Approves Zanubrutinib for Waldenström's Macroglobulinemia Treatment

Drug ApprovalRare Disease
  • The FDA has approved zanubrutinib (Brukinsa) for treating adult patients with Waldenström's macroglobulinemia, marking the second therapy specifically approved for this rare lymphoma.
  • The approval was based on the phase 3 ASPEN trial comparing zanubrutinib to ibrutinib, showing a higher very good partial response rate of 28% versus 19% respectively.
  • Zanubrutinib demonstrated improved tolerability compared to the first-generation BTK inhibitor ibrutinib across several clinically important side effects.
  • The drug is administered orally at either 160 mg twice daily or 320 mg once daily, offering patients a convenient single-agent treatment option.

A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)

NCT03053440CompletedPhase 3
BeiGene
Posted 1/25/2017

UK Approves First COVID-19 Monoclonal Antibody Treatment as AstraZeneca Reports 77% Efficacy in Prevention Trial

Monoclonal AntibodyDrug Approval
  • The UK's MHRA approved Ronapreve, the first monoclonal antibody therapy specifically designed to treat and prevent COVID-19, developed by Regeneron and Roche.
  • The treatment combines two monoclonal antibodies administered by injection or infusion, working by binding to the virus and preventing respiratory system entry.
  • AstraZeneca simultaneously announced that its AZD7442 antibody combination reduced COVID-19 symptom risk by 77% in a trial of 5,172 participants, with over three-quarters having comorbidities affecting vaccine response.
  • Both treatments represent significant advances for vulnerable populations who may not respond adequately to COVID-19 vaccines alone.

FDA Approves Aduhelm: First Disease-Modifying Alzheimer's Treatment in Nearly Two Decades

Drug ApprovalMonoclonal AntibodyNeurology
  • The FDA granted accelerated approval to Biogen's aducanumab (Aduhelm) as the first disease-modifying Alzheimer's treatment in nearly two decades, despite divided expert opinions on its clinical efficacy.
  • Aduhelm, priced at $56,000 annually, works by reducing amyloid plaques in the brain and will require monthly intravenous infusions with comprehensive clinical and MRI monitoring for potential adverse effects.
  • As part of the accelerated approval, Biogen must conduct a Phase 4 confirmatory trial, while experts view this approval as a potential catalyst for developing more effective Alzheimer's treatments targeting multiple pathways.

221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

NCT02484547TerminatedPhase 3
Biogen
Posted 9/15/2015

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

NCT02477800TerminatedPhase 3
Biogen
Posted 8/13/2015

A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities

NCT03639987TerminatedPhase 2
Biogen
Posted 12/20/2018

A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

NCT04241068TerminatedPhase 3
Biogen
Posted 3/2/2020

Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease

NCT01677572TerminatedPhase 1
Biogen
Posted 10/5/2012

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